Jump to content

CSL

Members
  • Posts

    0
  • Joined

  • Last visited

    Never

Everything posted by CSL

    • Full Time
    • 0
    • 0
    Für unsere Abteilung Engineering in Marburg suchen wir aktuell einen Spezialist Projekte Capex (m/w/d) R-214838 (Vollzeit / unbefristet / Tarif E11K *) Ausschreibungsende: 10.10.2023 Als Spezialist Projekte sind Sie Teil unsrer Projektsupport Organisation und unterstützen die effiziente Umsetzung der CAPEX Projekte in Marburg in einem interdisziplinären Projektteam Aufgaben Mitarbeit in komplexen lokalen und globalen CAPEX Projekten (Tier 1 bis Tier 3) und Übernahme von Teilprojektverantwortung im Bereich Projekt Management Office (PMO)Priorisierung und Koordinierung der Aktivitäten des Teilprojektteams (PMO incl. des Project Controlling) Überwachung der Projektbudgets und Management des Forecasts mit dem ProjektteamÜberwachung des Projektfortschrittes und des Projektplanes gem. Vorgabe des Projektleiters Kontinuierliche Bewertung des Projektfortschrittes und Darstellung des kritischen PfadesZeitplanung von Projekten abgleichen und auftretende Terminkonflikte mit den Projektbeteiligten/ Vorgesetzten lösen Selbstständige Klärung von komplexen, unvorhergesehenen Situationen im Rahmen der Projekte nach Rücksprache mit dem Vorgesetzen und dem ProjektleiterPräsentation des aktuellen Stands der zu betreuenden Teilprojekte in Deutsch und Englisch Erstellen und Verwalten des Projekt-Reporting in Zusammenarbeit mit dem Projektleiter (z.B. in Clarity)Mitarbeit bei der Erstellung des Projekterealisierungsplanes (Project Execution Plan), der Projektorganisation sowie des Projekt Risikomanagements und Mitarbeit am Projektmonitoring Identifizierung von Problemen/Konflikten; je nach Schwere des Problems/Konflikts eigenständiges Lösen bzw. Erarbeitung von Lösungsansätzen und Weiterleitung an den Projektverantwortlichen zur Entscheidung und Umsetzung in Zusammenarbeit mit dem VorgesetztenErarbeitung von Vorschlägen zur Prozessoptimierung sowie der Implementierung eines effektiven Prozesses, um abteilungsübergreifende Projekte unter Einhaltung firmeninterner Standards und Arbeitsanweisungen zu steuern (enge Zusammenarbeit mit der Abteilung Project Controls)Erarbeitung und Weiterentwicklung von neuen Tools im Bereich PMO und Controlling wie z.B. Ressourcenplanung, Reporting, Kosten und Terminplanung, auch mit Unterstützung externer Consultants)Best Practices auswählen, erarbeiten und festlegenMitarbeit bei der Festlegung von Standards für Capital Project sowie Sicherstellung der Anwendung in den Projekten Unterstützung und Schulung von Projektmanagern im Controlling (Ressourcenplanung, Kostenmanagement, Reporting)Point of Contact bei Problemen und Konflikten im Bereich Bestellungen, Rechnungen (enge Zusammenarbeit insbesondere mit den Abteilungen Finance, Einkauf) Sicherstellung einer regelmäßigen Kommunikation (z.B. regelmäßige Projektupdates und Berichterstattung in cross-funktionalen Teams, auch in englischer Sprache) Qualifikationen i.d.R. abgeschlossene 3jährige kaufmännische Ausbildung z.B. zum IndustriekaufmannEnglisch Level 2,Funktionsbezogene Weiterbildung z.B. zum Industriefachwirt4-5 Jahre Berufserfahrung Wenn Sie Fragen zu dieser Position haben wenden Sie sich bitte an Marko Witt, oder Mareike Hammerstaedt Senior Talent Acquisition Consultant. *Erfüllt der künftige Stelleninhaber (m/w/d) das Anforderungsprofil der Position nicht, so kann er abweichend von der Stellenausschreibung in einer anderen Tätigkeit mit reduziertem Aufgabengebiet beschäftigt und somit in eine niedrigere Entgeltgruppe eingruppiert werden. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America’s Best Employer for 2022 by Forbes magazine thus offer an exciting opportunity to join CSL as Metrology/Calibration Engineer. Perform activities related to Metrology expense and capital improvements to assure safe, timely, and efficient operations of Metrology assets. Responsible for developing, evaluating, and implementing cost-effective equipment, facility engineering solutions for a pharmaceutical manufacturing facility. This includes all phases of the expenditures including conception, developing justification, presenting to management, preparation of impact analysis, budget management, project timeline creation and management, detailed design, creating specifications (Design/Functional/System) and vendor/contractor scopes-of-work, competitive bidding, placing purchase orders, open Frontline projects and EAR’s, contractor and consultant supervision, creating and executing change control documentation (GCC’s), performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance/plant personnel as needed. This also includes project scheduling, tracking, and resource/ contractor allocation in regard to infrastructure assets, maintenance functions, and repair activities. Interfaces with Manufacturing, Metrology, Utility Services, Validation, QA, QC, R&D, Regulatory and various outside contractors. Role that this position reports to: Metrology Engineer Manager Role/s that report to this position: None Responsibilities: Support the planning and execution of plant and capital projects related to Metrology, with input and ownership of capital projects related to Metrology assets. Support shutdown schedule and meetings related to Metrology activities in VS areas. Assist with preparation and management of key Calibrations contracts – M2U. Share formalized continuous improvements based on supporting data, technical knowledge, engineering principles and current industry practices Ability to work with an engineering team and to work effectively in an engineering network. Establishing, tracking, and managing project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time, on-schedule and within budget. Undertake, direct, or assist others in the preparation and approval of Expenditure Proposals relating to Metrology projects and asset repairs. Also ensure, preparation of specifications, and other documentation that comprise the technical requirements for inclusion in bid packages and contracts. Ensure team members understand project objectives, specifications, deliverables, timelines and tasks through ongoing clear, concise communication & motivation of project team members Ensure that risk management methodologies and processes are followed in projects (expense and capital). Identify issues that may delay project deliverables and recommending appropriate risk mitigation strategies, contingencies, and actions to be taken. Reach out to other CSL sites and industry peers to ensure processes, equipment and personnel are Best in Class, (and/or consistent with industry trends). Participate in Regulatory Agency audits. Ensure all contracted contractors comply with all CSL safety standards and ISN program. Collaborate and provide ongoing project updates to senior management and functional leaders to ensure integration and achievement of project milestones. Work closely with site Operations and Quality management to manage and prioritize the production impact as it relates project deliverables and deadlines Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates, PSM, and OSHA requirements pertaining to Facilities infrastructure assets. Stay current with biopharmaceutical industry best practices and technologies. Completes any other duties/responsibilities assigned by senior management. Requirements: Bachelor’s Degree in Mechanical, Electrical or Chemical Engineering strongly preferred. The candidate must have 4+ years of experience in the pharmaceutical industry with extensive project management experience may be considered. Excellent knowledge of Metrology equipment maintenance and calibration practices is required Must know how to effectively run projects, coordinate contractors, and field the activities. A sound understanding of: Quality management systems and procedures. Risk management methodology and processes. Contract management and administration. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Responsibilities: Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demandsLeads multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirementsResponsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approvalProject Teams are responsible for completion of project lifecycle activities through turnover to routine commercial productionResponsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees Qualifications: MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred or local equivalent5+ years practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Quality AssuranceFunctional knowledge of cGMPs and manufacturing operations in FDA regulated facilityUnderstanding of project management principles and project lifecycle phases. Knowledge of Validation, CMC and facility regulatory submission requirementsFluent German and English Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. For our Technical Project Management Team, we are currently looking for a Technical Project Manager, based in Zurich to cover for maternity leave. In this function you report directly to the Head of Technical Project Management. You will be responsible for managing and/or supporting interdisciplinary Technical Operations/CMC projects across all CSL Vifor organizations. We are offering a flexible and hybrid working model. Your responsibilities will include, but will not be limited to: Lead and coordinate cross-functional CMC technical teams, involved in various activities around the development and life cycle management of CSL Vifor pharmaceutical products Initiate, plan and execute CMC technical cross-functional projects and activities (incl. CMC-development plan, technical project plan, budgeting and resource planning) Accountable for adequate stakeholder information/reporting on assigned program and project status Provide technical expertise to internal stakeholders for CMC decision making, incl. Contract Development & Manufacturing Organizations (CDMO) evaluations and negotiations Support DP pharmaceutical process establishment, technical transfers, process validation activities and manufacturing process optimizations Contribute to reviewing of documents associated with internal and external projects (i.e. Regulatory Filing, Qualification- and Validation Documentation, Master Batch Records, Product Quality Review, Deviation Reports, Risk Analyses, Failure Mode and Effects Analysis) Travel as needed to suppliers, CDMO and partner organizations for on-site meetings, incl. providing technical oversight and assist in trouble shooting as needed The ideal candidate holds an advanced degree in Life/Natural Science, Pharmacy or Engineering in addition to the following skills and experience: Experience in the management of interdisciplinary projects in an international environment, including working with international companies and contractors Experience in pharmaceutical industry including CMC processes and cGMP requirements, specifically for parenteral products Preferably experience in GMP manufacturing of sterile products (aseptic processing and terminal sterilization) Experience in the establishment and optimisation of pharmaceutical manufacturing processes including analytical methods Advanced communication and negotiation skills Fluency in English You are self-motivated Project Manager with hands-on mentality who brings advanced communication and negotiation capabilities. You describe yourself as a resilient and responsible person with distinctive teamwork skills. Your analytical mindset and your practice-oriented way of working ensure that you always have an overview and a pragmatic solution even in hectic situations. You are a role model for others in terms of the CSL Vifor Values and continuously display a positive can-do attitude. About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
    • Full Time
    • 0
    • 0
    Position Purpose: This position is responsible for the equipment reliability and maintenance strategy of utility and manufacturing equipment through continuous monitoring of equipment operational performance and implementing actions needed for improvement (Reliability-Centered Maintenance). Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA), root cause failure analysis (RCFA) and failure reporting, analysis, and corrective action system (FRACAS). Main Responsibilities and Accountabilities: 1. Serves as the technical lead and supports the improvement of equipment in the plant. Develop, implement and maintain equipment maintenance strategy and plans for plant equipment.Perform continuous improvement of maintenance PM’s, BOM’s and Spare Parts in support of compliance with applicable regulationsRecommend and implement measures through global initiatives to improve equipment that support utility and manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Provide engineering field support to identify, address and resolve operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life.Collaborate with Engineering in the equipment classification process, defining SAP Location hierarchy, populating asset information, developing Return-to-Service PM instructions and acquisition of equipment manuals.2. Conduct analysis of system maintenance process and perform reliability studies: Use of reliability tools and processes such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA)Uses data to recommend improvements based on CMMS, FMEA, RCA and systems reliability dataAnalyze equipment trends ensuring the maintenance program is effective3. Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements: Ensure that the Preventative / Predictive Programs and Maintenance Planning Processes are executedEvaluate new technologies (predictive tools) to be used by technicians and engineersAccountable to effectively apply PdM technologies and non-destructing testing to minimize unscheduled/scheduled maintenance downtime4. Monitor KPI’s: Measure and report reliability performanceDemonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics5. Subject Matter Expert (SME) for Internal and Regulatory Agency audits. 6. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability. 7. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance 8. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. 9. Completes any other duties/responsibilities assigned by senior management. Qualification Requirements: Bachelor’s Degree in Chemical, Mechanical, Electrical Engineering preferred or B.S. degree in an Engineering related field.Certified Maintenance & Reliability Professional, (preferred but not required)Certified Reliability Engineer, (preferred but not required) Experience Requirements: 5+ years of relevant experience and a BS3+ years of relevant experience and a MS.Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma.Experience in Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current, Liquid Penetrating testing, Dynamic/Static Motor Current testing, etcKnowledge of computerized maintenance management systems (CMMS).Prior experience in pharmaceutical industry is preferred.Proficient knowledge of Good Manufacturing Practices (GMPs)Strong verbal, technical writing and interpersonal skills are required.Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.Computer skills: MS Office Suite, MS Project, and AutoCAD. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader, motivated by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America's Best Employers for 2022 by Forbes magazine. Position Purpose: Provide leadership and direction to the Maintenance, Manufacturing and Utilities Engineering Programs. Implement strategy in alignment with functional goals and key Maintenance, Reliability Engineering, and Engineering objectives. Develops key objectives for global Maintenance Excellence Program and SAP Maintenance Program. This individual will work closely with a cross-functional leadership team to meet the needs of the groups supported. Role that this position reports to: Director, Utilities Engineering Role/s that report to this position: Reliability Engineers, Support Reliability Group Main Responsibilities and Accountabilities: 1. Provide strategic leadership and guidance in compliance and operational improvement of equipment systems based upon pharmaceutical industry trends and emerging technologies. 2. Ensure the Reliability Program is developed and implemented: Maintenance strategy and plans for new and modified equipment Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts for accuracy, efficiency and in support of compliance with applicable regulations. Works on problems of complex scope where analysis of scenarios or data involves multiple competing factors ​ 3. Manage and monitor KPI’s: Ensure compliance with site and global indicators Measure and report reliability performance Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics 4. Serve as functional lead for initiatives and strategy development related to Integrated Facilities Management (IFM) and Maintenance, Repair and Operations (MRO). Accountable for support all global level processes, policies, procedures, and execution related to Maintenance, Utilities, Facility and Engineering Reliability. Provides global governance support for the Maintenance Excellence Program in pursuit of best-in-class Maintenance and Reliability Engineering practices. Establishes analytical tools and reporting methods for network standardization. 5. Conduct analysis of system maintenance process and perform reliability studies: Use of reliability tools and processes such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA) Uses data to recommend improvements based on CMMS, FMEA, RCA and systems reliability data Analyze equipment trends ensuring the maintenance program is effective 6. Provide technical expertise and support: Ensure that the Preventative / Predictive Programs and Maintenance Planning Processes are executed Evaluate new technologies (predictive tools) to be used by technicians and engineers Accountable to effectively apply PdM technologies and non-destructing testing to minimize unscheduled/scheduled maintenance downtime Possess strong technical knowledge and application of concepts, practices, and procedures 7. Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life. 8. Recommend and implement measures through global initiatives to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. 9. Participate daily in leadership meetings providing technical support in all matters pertaining to operations and maintenance of the equipment systems. 10. Maintain clear communication with the Director of Utilities regarding goals, projects, planning, and overall performance of the Utilities. 11. Responsible for development of the department, placing a high priority on developing others through coaching, feedback and developmental goals where team members experience personal and professional growth. 12. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities. 13. Technical Representative for Regulatory Agency audits. 14. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. 15. Completes any other duties/responsibilities assigned by senior management. Position Qualifications and Experience Requirements: Education Bachelor’s Degree in Chemical, Mechanical, Electrical Engineering preferred or B.S. degree in an Engineering related field. Certified Maintenance & Reliability Professional, preferred Certified Reliability Engineer, preferred Experience 7+ years of experience in an engineering management role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma Demonstrated experience in Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current, Liquid Penetrating testing, Dynamic/Static Motor Current testing, etc Proficiency in Power BI is a plus Experience with Quality Management and Change Control Systems. Knowledge of computerized maintenance management systems (CMMS). Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility Knowledge & experience in the operations and maintenance of utility systems Knowledge of manufacturing processes Strong Leadership skills Financial experience with high level budgetary responsibilities Computer skills: MS Office Suite, MS Project, and AutoCAD. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Responsibilities: Serves as the technical lead and supports the specification, installation, utilization, qualification, and improvement of equipment used for assigned manufacturing area. • Understands the functionality and operation of the equipment. • Responsible for the current and future design of the equipment/system. • Accountable for keeping technology current. • Identifies and implements best demonstrated practices (via Communities of Practice and/or other methods). • Owns SOP/work instructions for operating system/equipment. • Develops training and troubleshooting guides. Ensure the technical reliability as well as the safety of production facilities in the assigned manufacturing department. Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE). • Evaluates and updates PMs to keep system performance optimal. • Implements and monitors predictive maintenance of the system to prevent breakdowns of the system. • Implements and monitors TPM to ensure the system stays in like-new condition. Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering and Manufacturing. • Ensures the system can be operated safely by the operators. • Minimizes quality deviations and discards associated with the system. • Maximizes efficiency/OEE, yield, output, & capacity of the system. • Updates maintenance and calibration plans collaborating with the expert groups. Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies. • Prevents obsolesce of system parts and components that can impact safety, quality, and reliability. • Oversees reconditioning of the equipment to restore to like-new condition. • Performs upgrades to improve safety, operational performance, and extend operational life. • Develops end-of-life replacement plan for the system to ensure reliable supply to our patients. • Collaborates with local and global partners to develop asset management plan that includes capital requests. Ensure equipment and processes are compliant with the government regulations. Acts as equipment SME during internal or external Regulatory inspections. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Qualifications: Requires a bachelor’s degree in Mechanical, Chemical or Manufacturing Engineering. • 4+ years of relevant experience and a BS • 2+ years of relevant experience and a MS. • Strong verbal, technical writing and interpersonal skills are required. Strong communication skills with customers, design teams, contractors, and management • Action oriented skills; ability to learn on the fly • Good problem solving, technical learning, time management and prioritizing skills • Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility. Prior experience in pharmaceutical industry is preferred. • Proficient knowledge of Good Manufacturing Practices (GMPs) • Audit and Investigation Skills, Report Writing Skills. • Proficiency in Microsoft Office applications. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    The Role The Utilities Engineering Department provides maintenance services across the CSL Broadmeadows site. Reporting to the Maintenance Engineer you will be a Mechanical Technician where you will oversee the upkeep of systems, plant and equipment. Working a 9 day fortnight from 7am to 3:40pm, you will be able to assess, diagnose and repair root cause issues with mechanical systems, plant and equipment and have experience conducting preventative maintenance tasks, inspections, corrective and breakdown maintenance. You will: Carry out corrective and preventative maintenance on mechanical systems, plant and equipment which will include repairs and start up and shut down of the plantsAssist the Maintenance Engineer as and when required with the planning, scheduling and conduct of major workWork on different pumps, air handling units, boilers, cooling towers. Air compressors and heat exchangers, agitators, multiple valves and other mechanical equipmentWork on hydraulic and pneumatic equipmentWork inside tanks following confined space entry procedures to conduct inspectionsProvide general maintenance solutions to improve plant equipment availability and reliabilityFabrication work to address process or equipment maintenance problems. using MIG, TIG, Arc, Oxy welding You will have: Indentured qualification as a Mechanical Technician/ Fitter & Turner or similar trade qualificationExperience in trouble shooting, fabrication and general maintenance activitiesExperience with condition monitoring techniques such as vibration analysis, oil sampling and carrying out steam trap audits will be an advantage.Commitment to Occupational Health, Safety and Environment.Flexibility in working hours to meet our needs, including shift patterns, working during facility shutdowns and be available after hours to support manufacturing.Honest, autonomous and enjoy utilising your initiative to solve mechanical related problems in the process and plant environmentExperience working within a regulated/GMP environment and an understanding of the strict hygiene and traceability standards that apply will be highly regarded. Apply now to join a growing, large manufacturing facility! Please submit your application in one document. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Your role Plasma fractionation at CSL ensures different types of proteins found in plasma are separated, purified and concentrated into therapeutic doses. Our Senior Automation Engineers, internally referred to as the Senior Value Stream Recipe Owner, are primarily accountable for the implementation, maintenance and ownership of the PCS/MES and PLC process recipes. Your responsibilities Reporting to the Value Stream Recipe Owner Lead you will: Technical project subject matter expert for Execution Systems related project deliverables. Including oversight and review of contractors/integrators work during design, construction, commissioning, and validation phases of CAPEX projects and OPEX programs & changesOversee the process recipe and configuration across the MES, PCS and PLC systemsCoordinate interfaces with the Data Historian, Data Acquisition Systems, Building Management Systems, Central Alarm Management System, Manufacturing Control Network, and Enterprise applicationsEnsure the recipe design and implementation meets Engineering and Manufacturing requirements for operating the plantEnsure that project work is completed within budget and on schedule and observing the project management methodology as defined in QMSSeek opportunities for optimisation of the design, programming and test activities within the Execution System scope Your experience Bachelor of Science in an Engineering or other Science discipline i.e. Computer Science or Management Information Systems.At least 5 years' practical experience in pharmaceutical industry including direct experience in Manufacturing, Engineering or Execution Systems/AutomationSpecific experience in process automation, MES and batch manufacturing industry standardsHands-on experience in Recipe and Workflow Authoring (e.g.: Base Fractionation, Manufacturing, Packaging) or experience configuring master data and equipment in MESDirect experience designing, building, deploying and supporting automation and execution systems in a regulated large-scale process-based manufacturing environment To apply submit your CV no later than Monday 27th November 2023 #LI-Onsite Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Position Purpose: This position is responsible to oversee and drive the development and execution of an Energy and Sustainability Management Program to meet the energy and sustainability objectives for the plant. Track, analyze and report on global energy metrics, greenhouse gas emissions, sustainability initiatives including electricity, gas, water, and solid waste reduction and diversion. Main Responsibilities and Accountabilities: 1. Responsible for the development and management of the energy and sustainability program: Identify strategies to address, measure and verify energy efficiency to reduce waste/carbon emissionsCoordinate and conduct site energy audit assessments (surveys)Identify, evaluate, promote and manage energy and carbon reduction projectsImprove current data collection methodsDevelop and implement a multi-year plan tracking progress towards the sustainability goals and recommend global targetsReview operations and maintenance (O&M) schedule and procedures for operational savings 2. Strategic engagement of internal and external networks to help deliver sound technical decisions Maintain knowledge of changes in the energy markets alerting the business to potential impacts.Coordinate with energy advisors to analyze, report on consumption metrics and identify opportunities during contract negotiationsParticipate in stakeholder events for energy leaders in IllinoisResponsible for the utility monthly variance reports highlighting forecast vs actual performance.Responsible for monitoring and coordinating all future demands (day ahead forecast) with utility providers. 3. Responsible for the Energy Management Program: Energy Management System (EMS) data collectionExecute analysis to identify trends and facilitates environmental sustainability communicationCreate dashboards and performance reports for utility and production billing metricsPerform measurement tracking on usage, cost reduction and avoidanceEvaluate and integrate performance metrics to drive efficiency KPI'sImplement ISO 50001 energy management system and federal energy efficiency programs 4. Identify and implement energy conservation measures (ECM) Performance/efficiency of conversion systems such as boilers, chillers, and compressorsEvaluate significant energy users and ways to drive continual improvementDetail potential energy conservation and cost savings measuresDevelop utility usage and cost by various departments within the facilityPerform metering/instrumentation gap assessments and deliver project planDeliver Net Zero master plan 5. Collaborates within the CSL network to share best practices and align energy reduction opportunities. 6. Subject Matter Expert regarding building, energy management and environmental sustainability systems. 7. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance 8. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. 9. Completes any other duties/responsibilities assigned by senior management. Position Qualifications Requirement: Bachelor’s Degree in Chemical, Mechanical, Electrical Engineering or B.S. degree in an Engineering related field. Position Experience Requirements: 5+ years of relevant energy engineering experience and a BS 2+ years of relevant experience and a MS Experience with standard ASHRAE energy calculations, ASHRAE Level 1 and Level 2 audits, optimizations, linear regression modeling, etc Strong understanding of mechanical and electrical systems, energy and water efficiency standard methodologies. Knowledge of building management systems, controls and HVAC systems, chillers, cooling towers, natural gas boilers, compressed air systems, Cogen and pumping systems. Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility Knowledge of computerized maintenance management systems (CMMS) Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Financial experience with budgetary responsibilities Prefer Energy Manager Certification and strong skills and AutoCAD Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Responsibilities: Serves as the technical lead and supports the specification, installation, utilization, qualification, and improvement of equipment used for assigned manufacturing area. • Understands the functionality and operation of the equipment. • Responsible for the current and future design of the equipment/system. • Accountable for keeping technology current. • Identifies and implements best demonstrated practices (via Communities of Practice and/or other methods). • Owns SOP/work instructions for operating system/equipment. • Develops training and troubleshooting guides. Ensure the technical reliability as well as the safety of production facilities in the assigned manufacturing department. Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE). • Evaluates and updates PMs to keep system performance optimal. • Implements and monitors predictive maintenance of the system to prevent breakdowns of the system. • Implements and monitors TPM to ensure the system stays in like-new condition. Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering and Manufacturing. • Ensures the system can be operated safely by the operators. • Minimizes quality deviations and discards associated with the system. • Maximizes efficiency/OEE, yield, output, & capacity of the system. • Updates maintenance and calibration plans collaborating with the expert groups. Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies. • Prevents obsolesce of system parts and components that can impact safety, quality, and reliability. • Oversees reconditioning of the equipment to restore to like-new condition. • Performs upgrades to improve safety, operational performance, and extend operational life. • Develops end-of-life replacement plan for the system to ensure reliable supply to our patients. • Collaborates with local and global partners to develop asset management plan that includes capital requests. Ensure equipment and processes are compliant with the government regulations. Acts as equipment SME during internal or external Regulatory inspections. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Qualifications: Requires a bachelor’s degree in Mechanical, Chemical or Manufacturing Engineering. • 4+ years of relevant experience and a BS • 2+ years of relevant experience and a MS. • Strong verbal, technical writing and interpersonal skills are required. Strong communication skills with customers, design teams, contractors, and management • Action oriented skills; ability to learn on the fly • Good problem solving, technical learning, time management and prioritizing skills • Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility. Prior experience in pharmaceutical industry is preferred. • Proficient knowledge of Good Manufacturing Practices (GMPs) • Audit and Investigation Skills, Report Writing Skills. • Proficiency in Microsoft Office applications. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Summary: The Site Validation Lead oversees the team accountable for planning and executing process and cleaning validations, ensuring compliance with company standards and governmental regulatory requirements; considering adequate risk-benefit aspects; investigating and troubleshooting validation problems. S(he) is also accountable to provide adequate resourcing for validation activities. S(he) is the main point of contact to the Center of Excellence (CoE) Validation group and assists with establishing corporate validation policies on site. This role manages a small to mid-sized team which may consist of both experienced professionals and managers. S(he) supports and understands validation needs for both projects as well as routine validation activities and focuses on policy and strategy implementation for short to mid-term results (e.g., 1-2 years). Requires ability to influence others to accept practices and approaches, and ability to communicate outside own functional areas. Problems faced are often complex and require extensive investigation and analysis. Responsibilities: • Assessment of validation requirements for changes and projects • Responsible for providing validation support and staffing for projects • Accountable for ensuring that all manufacturing processes on site remain in a validated state, including cleaning processes • Responsible for providing adequate staffing for routine/regularly recurring validation activities • Oversees writing and reviewing of documents for required registrations and providing adequate responses to regulators regarding validation topics • Responsible for leading and performing process risk assessments for the site manufacturing processes using defined risk management tools • Responsible for providing input to deviations related to validation activities: support of the root cause analysis and CAPA definition as required • Identification and closure of validation gaps on site to minimize compliance risks • Key point of contact in inspections for all validation related topics • Accountable for tracking key validation KPIs on site • Liaises/aligns with the other site teams and the CoE on validation topics • Responsible for providing input to and agreeing on new or changes to relevant validation concepts, procedures, policies, standards • Responsible for applying validation procedures to ensure compliance with global standards and regulatory guidelines • Defines the validation strategy and the validation effort required for registrations (new license applications, extension of registrations, changes) in close collaboration with the CoE • Ensures the implementation and execution of the defined validation strategy considering optimization of costs and effort (e.g. with innovative and risk-based approaches) • Drives continuous improvement and innovation for validation processes on site in close collaboration with the CoE • Communicates and manages implementation of validation concepts and standards on site • Defines and communicates site validation objectives to ensure adequate prioritization, planning and timely execution of validation activities • Responsible for defining the long-term staffing strategy based on the validation requirements in collaboration with the PE site head • Establishes performance goals and strategic/operational objectives for direct reports • Coaches, counsels, and appraises performance of personnel. • Develops staff competencies & capabilities to enable sustained success and career development. • Promotes high employee engagement and a positive work environment. • Establishes and maintains a culture of learning and continuous improvement through capturing lessons learned and networking • Responsible for budget resource requirements and staffing decisions in collaboration with the PE site head • Promotes customer focus within the site validation team and collaborating with stakeholders in the Value Streams, QC, Process Engineering, QA, Regulatory Affairs and other functional areas. Competencies: • Customer Orientation (Internal/External): Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs. • Drives results: Consistently achieving results, even under tough circumstances. Has a strong bottom-line orientation and persists in accomplishing objectives despite obstacles and setbacks. Has a track record of exceeding goals successfully. Pushes self and helps others achieve results • Collaboration and Influencing: Champions a culture of inclusiveness and teamwork. Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value. • Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus. • Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably. • Develops talent: Developing people to meet both their career goals and the organization’s goals. Places a high priority on developing others. Develops others through coaching, feedback, exposure, and stretch assignments Qualifications: • Degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred • 8+ years’ experience in pharmaceutical manufacturing quality or operations management in a cGMP environment; 3+ year’s validation experience • Leadership/management experience • Knowledge and experience with biologicals and aseptic processing • Knowledge of current regulations and guidelines, industry standards and best practices for validation of biopharmaceutical products • Knowledge of quality by design principles and tools Please attach you resume. Applications will close on 21 November 2023. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    The Opportunity CSL Behring is a world class manufacturer of blood plasma proteins which are used to treat human immune deficiencies and severe autoimmune diseases. As our organisation continues to grow, we have a position available within our Engineering group as an Engineering Data Support who is a custodian of Engineering data on SAP. This is a permanent full-time position and hybrid, flexible work is available. Reporting to the Engineering Data Manager, you will support the engineering data management activities to provide high quality, user focussed support services. You will help manage Engineering data in SAP, support processes. Engineering data includes Assets, Preventive Maintenance, Calibration data and Engineering Materials. The Role Data cleansing and transformation activities in preparation for loading into databaseReview and respond to service requests from site usersIdentify potential risks to GxP compliance and implement solutions for improvementTroubleshoot and resolve system issues as they arise, escalate as requiredComplete system testing of improvements/fixesExtract data and develop reports to support site user requirementsDeliver training to new users Your skills and experience Relevant Engineering or Science degree, or related TAFE qualification2 years experience in a similar function/rolePrevious SAP experience (S4 HANA preferred), LSMW experience desirableUnderstanding of GMP and quality requirements in manufacturing/maintenance is idealAdvanced Excel skills and a sense of ownership of the data that we manage, to ensure that it is as correct and complete as possibleStrong attention to detail and logical problem solving How to Apply Please submit your application including the CV by Monday 27th November 2023. Apply now to join Australia's largest pharmaceutical manufacturer. Our passion is to save lives and protect health in people everywhere. At the core of our DNA is a resolve to always be innovating for our patients! #LI-Hybrid Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. CSL’s Co-op Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The 26-week experience will immerse students in meaningful, thought-provoking projects that contribute to CSL's promise to save lives and protect the health of people around the world. In addition to making an impact, students will be developed personally and professionally while cultivating meaningful relationships. Main Responsibilities •Execute multiple project or manufacturing support tasks in a cGMP environment; and understands regulatory and quality assurance requirements/impact •Support and assist with the development and review of controls GMP compliant Qualification Protocols. •Support manufacturing automation systems, which may include (but not limited to) documentation and programming changes. •Support and assist with the development and review of controls GMP compliant Qualification Protocols. •Support controls code change control process. •Support and assist in the development of end user training and training plans. Qualifications •Enrolled in a 4-year university with progression toward an undergraduate degree in Computer Science, MIS, Engineering or related field •Excellent communication and presentation skills •Ability to work well with all levels of the organization •Demonstrates flexibility and acceptance of assignments and schedules •Enthusiasm to learn new tools & technologies •Maintains professional behavior Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Your role At our manufacturing facility in Broadmeadows, Victoria, CSL produces a comprehensive portfolio of medicines and therapeutics including critical care products for use in blood loss and immunoglobulins to help protect against infection by life-threatening bacteria or viruses. You will manage planning and developing Engineering requalification activities, ensuring our manufacturing activities for these life saving products are implemented to industry and regulatory standards. Your Responsibilities Reporting to the Manager – Requalification you will: Perform Requalification, Document Review, Preparation of Reports, Temperature and Humidity monitoring, Sterilisation and Requalification equipment maintenance - in compliance with relevant regulatory codesManagement & maintenance of departmental equipmentMonitoring equipment spotcheck reviewsSAP changesFacilitating & maintaining equipment calibrationsEnsure training is maintained and train new staff as required Your experience A relevant science or engineering tertiary qualification (or suitable experience)At least 3 years experience in the pharmaceutical manufacturing industry, although similar experience within other, regulated, manufacturing industries will also be consideredSound knowledge of cGMP and industry guidance documents and standards in addition to an understanding of qualification principlesAn Intermediate to Advanced knowledge of MS ExcelGood verbal and written communication skillsSound problem solving and negotiation skills and a strong customer focus To apply submit your CV no later than Monday 4th December 2023 #LI-onsite Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support in the following utility equipment systems: Clean Utilities (Clean Steam, Purified Water, WFI and RO Systems), HVAC Systems, Plant Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Natural Gas, Bulk Chemical Distribution, Solvent Gas Detection systems, Water, Cooling towers and Waste Treatment systems for the Kankakee facility. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: 1. Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies: Responsible for compliance and operational improvement of equipment systems Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life Implement measures to improve equipment that support utility operations Provide support in all matters pertaining to engineering, operations and maintenance of the equipment systems Provide technical expertise and industry best practices Lead troubleshooting efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports. Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering. Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings. 2. Accountable for the Utility Reliability Program: Execute the maintenance strategy for new and modified equipment Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Oversees reconditioning of the equipment to restore to like-new condition Performs upgrades to improve safety, operational performance, and extend operational life Collaborates with local and global partners to develop asset management plan that includes capital requests 3. Manage and monitor KPI’s: Ensure compliance with site and global indicators Measure and ensure compliant performance in Safety, Quality and Reliability Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics Utilize control systems to monitor, trend and verify equipment performance and downtime 4. Ensure cGMP compliance of all utility systems to meet regulatory compliance: Equipment is maintained at a level required to provide high reliability maximizing useful life Review environmental monitoring and laboratory sample release test results Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production Execute root cause analysis around equipment and operational events, owning change controls, investigations Lead investigations as the subject matter expert providing technical expertise for all phases associated with the operation and troubleshooting of the utility systems Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents. Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis. Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures. 5. Required to support all scheduled utility system shutdowns, tie-ins and system startup. 6. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability. 7. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. 8. Completes any other duties/responsibilities assigned by senior management. Additional Responsibilities and Accountabilities (Waste Water): 1. Perform calculations for proper mixture, chemical flow rate based on engineering principles maintaining compliance to federal, state, and local regulations. 2. Participates in operations activities to review, analyze and interpret environmental monitoring data along with reviewing wastewater permit and permit compliance. 3. Assist with environmental laboratory technical studies, which may include reviewing sample collections, laboratory tests and analyses. 4. Performs data evaluation, design support, assist with reviewing hydraulic analysis and modeling of water and wastewater systems. 5. Support daily operations of the wastewater system and equipment. 6. Oversee the overall equipment lifecycle of the site's wastewater system; including pH neutralization, anaerobic and aerobic treatment processes, dissolved air floatation, dewatering centrifugation, and chemical feed systems 7. Collect and analyze data for use by the operations manager to ensure reliable operation of the wastewater systems. Additional Responsibilities and Accountabilities (Plant System): 1. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Plant Utility systems. 2. Play an essential leadership role in the operation to troubleshoot and diagnose system problems utilizing utility technicians and external resources on project and operational support activities. 3. Responsible for the Utility generation and distribution systems across the site. These systems include domestic/potable/industrial water, cooling tower water, soft water, plant steam (boilers and cogen), gas and other ancillary equipment. 4. Technical lead in engineering, with a focus on plant utility systems, industry best practices, and emerging technologies related to utility systems requirements. Position Qualifications and Experience Requirements: Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field. 5+ years of relevant experience and a BS 3+ years of relevant experience and a MS Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Strong knowledge of utility systems (Clean and Plant Utility Systems) Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s. Must have experience with mid-to-large capital projects for the pharmaceutical industry. Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials). Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Experience with Quality Management and Change Control Systems. Knowledge of computerized maintenance management systems (CMMS). Excellent problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects. Knowledge of manufacturing processes Computer skills: MS Project and AutoCAD preferred Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Provide leadership and support site core processes by managing and coaching Metrology Technicians to ensure on time completion of calibration activities. Collaborate with Metrology Manager and Metrology Engineers to identify areas of opportunities, troubleshoot and resolve any area issues to avoid downtime. Support implementation of continuous improvement actions related to metrology processes; to ensure Kankakee site needs are consistently met within boundaries of compliance, quality, time, and budget. This position supports a culture of continuous improvement by collaborating with Metrology Manager. Ensure current Good Manufacturing Practices and Standard Operating Procedures are integrated and followed in all activities. Instrumental to the overall success of the Value Streams by ensuring Metrology activities are completed on a timely manner and metrology systems and policies are followed. Main Responsibilities and Accountabilities: Supervises the activities of Metrology hourly personnel and assigned Maintenance hourly personnel. Assists with scheduling and execution of activities to ensure appropriate coverage. Responsible for handing out disciplinary action when required. Assists in the training and development of hourly personnel. Acts as supervisor in coordinating engineering projects, PM’s, daily workload and assigning duties for clear direction of the department. Enforce plant and department policies and procedures. Schedules system PM’s and coordinates maintenance activities for equipment while minimizing impact on production schedules. Ensures all safety guidelines are followed for all personnel working in assigned area. Collects and monitors data to ensure a timely and accurate response to system problems. Elevates cGMP related issues to management and Quality Assurance. Assists in QA investigations, OOT’s, CAPA’s, etc. Interfaces with outside suppliers and community representatives to ensure; the highest quality input into the facility’s primary utilities and timely resolution to issues. Frontline representation to Regulatory Agencies, HS&E, State inspections, Insurance inspections, etc. Orders supplies and materials required for repairs, PM’s, safety, and housekeeping requirements including but not limited to hazardous materials, caustic, ammonia, bulk salt etc. Coordinates purchase and deliveries of these materials. On call to ensure compliance with cGMPs and regulatory requirements; provides timely notification to our customers on issues, their causes, duration, and resolution. Troubleshoots and coordinates efforts to keep systems running within defined parameters. Provides support as Subject Matter Expert during regulatory audits. Essential point of contact for all Engineering projects. Coordinates startup, shutdown, and isolation activities within the scope of plant projects, repairs, facility startups, etc. Review, author and revise SOP’s, specifications, drawings etc. Engineer, design, implement, proceduralise and validate assigned projects within Metrology areas of Facility (House) Steam, City Water, Ammonia System, CoGeneration, Hot and cold Glycol systems and Compressed Air Generation. Responsible for completing and assisting projects through defined Change Control, Risk Assessments, Capital and Expense procedures. Completes any other duties/responsibilities assigned by senior management. Qualification Bachelor’s Degree in Mechanical, or Chemical Engineering preferred with 2 years’ experience in primary utilities or demonstrated ability. In lieu of a bachelor’s degree an Associate degree with a minimum of 5 years of experience or demonstrated ability. Experience in Metrology functions within the pharmaceutical industry and/or plant engineering, machine engineering or process engineering in pharmaceutical, food or chemical industry is required. Knowledge in plant maintenance, Metrology / Calibration, and manufacturing processes. 2+ years of relevant experience and a BS 5+ years of relevant experience and a AS. Proficient knowledge of Good Manufacturing Practices (GMPs) Experienced to act as a situational leader for internal and external customers. Audit and Investigation Skills, Report Writing Skills. Ability to develop cohesive presentations Strong verbal, technical writing and interpersonal skills are required. Computer Literacy (Microsoft Office applications, Trackwise, SAP, other) Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents. Knowledge of multiple problem-solving methods (i.e., Six Sigma, Statistical Process Control, Design of Experiment, Fish Bone Analysis, 8D, etc.) Communicate Effectively - Written and Verbal Collaboration Instills Trust Results Driven – Problem Solving Situational Adaptability Action Orientated Drives Engagement Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
    • Full Time
    • 0
    • 0
    Your role The Project Banksia team for constructing our state-of-the-art Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia’s public health needs such as snake and spider antivenoms. This role supports elements of the Clean Utilities design and execution for the Banksia capital project. Clean Utilities includes special waters (PW, WFI, clean steam), process gases, bulk chemicals, and waste treatment. Your responsibilities Coordinate/Oversee the project lifecycle (Design, Procurement, Construction, Commissioning and Qualification) for their section of the utilities scope according to the project objectives and requirements (Utility URS and equipment TRS).Managing design and works to meet the project budget and schedule, GMP, safety and environmental requirements. This may include:o Equipment design for Clean Utilities o Clean Utilities Design Qualification o Clean Utilities Equipment procurement o Clean Utilities Equipment FATs o Off-site Fabrication and On-site installation of Utilities equipment and pipework o FAT (Factory Acceptance Testing) o SAT (Site Acceptance Testing) o Commissioning of the Utilities o Qualification of the Utilities Prepare and complete CEQ documentation, and assist with project management documents (progress reports, design reviews)Contribute to value engineering initiativesCollaborate in teams as Subject Matter Experts (SMEs) Your experience A bachelor’s degree in a relevant Engineering fieldAt least 3 years' engineering or construction project managementExperience with the process and engineering systems within the Pharmaceutical Industry;Experience in project management with the ability to lead and deliver a project.A demonstrated ability to lead and work closely with multiple stakeholders to deliver large or highly complex projects;Financial experience in managing budgetary responsibilities;Automation and in particular PCS7 experience is advantageous;A good understanding of quality, risk and contract management processes and procedures; To apply submit your CV no later than Monday 27th November. #LI-Onsite Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!
    • Full Time
    • 0
    • 0
    ​ ​Job Description SummaryResponsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification.Job Description1 Promotes positive customer relations with all donors. 2 Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. 3 In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. 4 Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. 5 Notifies and counsels donors regarding reactive test results. Refers donors to community facilities for follow-up and counseling. 6 Explains informed consent to applicant donors. This includes explanation of procedures, hazards and potential adverse events; explanation of immunization schedules, dose and antibody response; providing clear opportunity for donor to refuse participation; obtaining signature and date certifying informed consent. 7 Handles medical emergencies at the Center by providing routine care as outlined in Standard Operating Procedures (SOPs); elevates situations to Center Physician or local medical service providers as required. Periodically checks emergency kits to assure supplies are present and in-date. 8 Reviews test results and determines continued donor suitability. Follows SOPs regarding acceptable ranges of four-month required test (PE/STS) reports. Maintains knowledge of and apply all rules regarding four-month approvals and grace periods. 9 Assess signs and symptoms a donor may exhibit that may result in the inability to continue donating. 10 Manages employee hepatitis B and influenza immunization program, including administration of immunizations. 11 Understands the policies and procedures associated with hyper immune programs at the center where applicable, and oversees donor immunization programs. Reviews antibody titer results as required. Maintains awareness of appropriate immunization schedule for each antigen. 12 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation. 14 Maintains confidentiality of all personnel, donor and center information. 15 May be cross-trained in other areas to meet the needs of the business. 16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 17 Perform other job-related duties as assigned. Education • Graduation from a paramedic, nursing, physician assistant, chiropractic, medical school or naturopathic medical training program • If graduation is from a foreign allopathic or osteopathic medical school, must also currently be licensed as a physician or state certification as an emergency medical technician Experience • Minimum of one (1) year experience in a health care environment • Experience in a plasma or whole blood collection center or other regulated environment preferred • Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc. • Ability to instruct donors, staff and community regarding the benefit of plasma donation programs Working Conditions (physical & mental requirements) • Ability to make decisions, which have moderate impact on immediate work unit. • Ability to understand, remember and apply oral and/or written instructions • Must be able to see and speak with customers and observe equipment operation • Occasionally perform tasks while standing and walking up to 100% of time • Examine and assess the skin and other abnormalities through sight, touch and smell • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    Job Description SummaryResponsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. Job Description1 In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. 2 Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. 3 Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. 4 Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. 5 May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. 6 Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variances. 7 Conducts daily calibration of equipment according to SOPs. 8 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 9 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11 Maintains confidentiality of all personnel, donor and center information. 12 May be cross-trained in other areas to meet the needs of the business. 13 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in laboratory or warehouse environment preferred or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions (physical & mental requirements) • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    The Opportunity Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs). You will report to the Assistant Center Manager The Role In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect.In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally.Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff.Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues.Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service.Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader or Supervisor of donor flow issues.Collects arm samples or whole blood samples from donors for testing.Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).Understands the policies and procedures associated with hyper immune programs at the center if applicable.Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation.Maintains confidentiality of all personnel, donor and center information.May be cross-trained in other areas to meet the needs of the business.Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.Perform other job-related duties as assigned. Your skills and experience Education High school diploma or equivalent required Experience Minimum eighteen (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience Working Conditions (physical & mental requirements) Ability to complete routine forms or conduct routine oral communicationsUnderstands, remembers and communicates routine, factual informationMust be able to see and speak with customers and observe equipment operationOccasionally perform tasks while standing and walking up to 100% of timeReach, bend, kneel and have high level of manual dexterityOccasionally be required to lift and carry up to 25 poundsFast paced environment with frequent interruptionsFrequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogensRequired to wear Personal Protective Equipment while performing specific tasks or in certain areasRequired to work overtime and extended hours to support center operational needs Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    Job Description SummaryResponsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. Job Description1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 3 May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. 4 May answer the telephone and answer callers question or transfer call to appropriate staff member. 5 Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. 6 Alerts Group Leader or Supervisor of donor flow issues. 7 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 8 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 10 Maintains confidentiality of all personnel, donor and center information. 11 May be cross-trained in other areas to meet the needs of the business. 12 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 13 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    Job Description SummaryResponsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. Job Description1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 3 May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. 4 May answer the telephone and answer callers question or transfer call to appropriate staff member. 5 Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. 6 Alerts Group Leader or Supervisor of donor flow issues. 7 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 8 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 10 Maintains confidentiality of all personnel, donor and center information. 11 May be cross-trained in other areas to meet the needs of the business. 12 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 13 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    Job Description SummaryResponsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. Job Description1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 3 May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. 4 May answer the telephone and answer callers question or transfer call to appropriate staff member. 5 Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. 6 Alerts Group Leader or Supervisor of donor flow issues. 7 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 8 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 10 Maintains confidentiality of all personnel, donor and center information. 11 May be cross-trained in other areas to meet the needs of the business. 12 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 13 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
    • Full Time
    • 0
    • 0
    Job DescriptionJob Description SummaryResponsible for preparing the donor, donor area and equipment for the pheresis process. Job DescriptionMain Responsibilities 1. Prepares the autopheresis machine for the pheresis process. 2. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3. Disconnects the donor when the process is complete. 4. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6. Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7. Alerts Group Leader or Supervisor of donor flow issues. 8. Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 9. Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10. Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11. Maintains confidentiality of all personnel, donor and center information. 12. May be cross-trained in other areas to meet the needs of the business. 13. Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14. Perform job-related duties as assigned. Education  High school diploma or equivalent required Experience  Minimum of three (3) months’ work experience, preferably in medical or health provider environment or equivalent combination of education and experience  Must be able to perform basic math calculations Working Conditions (physical & mental requirements)  Ability to understand, remember and apply oral and/or written instructions  Ability to understand and follow basic instructions and guidelines  Must be able to see and speak with customers and observe equipment operation.  Occasionally perform tasks while standing and walking up to 100% of time  Reach, bend, kneel and have high level of manual dexterity  Occasionally be required to lift and carry up to 25 pounds  Fast paced environment with frequent interruptions  Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens  Required to wear Personal Protective Equipment while performing specific tasks or in certain areas  Required to work overtime and extended hours to support center operational needs Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!
×
×
  • Create New...