COMPLETE Technologist - Toronto, ON

Reference No. R2722146

Position Title: Technologist

Duration: Fixed-Term Contract, February 5, 2024 - February 5, 2027 (Subject to change)

Department: MWS (Influenza Vaccine Manufacturing)

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 

Major Activities of the Job:

Execution of  Media,  Washing,  and Sterilization & Upstream activities:

• Assist  in review  of Records,  SOP, logbooks,  and monitoring charts  for completion and ensure  accuracy of alI documents as per GMP  guidelines.

• Train and ensure technical  staff  comply  to GMP,  HSE, and SOP requirements.

• Participate in daily meetings and report  findings to management.

• Participate in deviation investigations and root cause analysis.

• Coordinate with units within department (MWS, Upstream and Downstream)

• Provide training to personnel.

• Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.

• Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to B200 operations (MWS, Upstream and Downstream processes).

Preparation of media, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, warehouse:

• Perform activities and documentation involved in MWS and Upstream including, in buffer preparation, washing and sterilizing, inoculation preparation, infectivity testing, and material handling.

• Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.

• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.

• Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.

• Provide guidance to technical staff on problem solving and trouble shooting.

• Ensure area is inspection ready. Knowledgeable to guide inspectors.

• Material handling, movement an organization and storage. Reorder parts as per guidance from TGL's

Administration of data for Influenza drug substance operations:

• Document and review production and monitoring activities for Influenza drug substance manufacturing

• Complete SAP transactions in a timely, accurate manner.

• Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).

• Ensure all data is completed timely and accurately in LIMS, Master, Change Request Forms, PCS and EM system.

Health,  Safety, and Environment  and maintenance of GMP environment:

• Participate in keeping  the production area and office areas in a tidy, GMP manner, following 5S guideline or equivalent and supply  materials as required.

• Disinfect area as required in SOP.

• Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.

• Use proper PPE when performing tasks.

• Follow HSE SOP's, identify and minimize risks, promote safety culture.

• Ensure chemicals are stored as per HSE requirement and has MSDS available.

Process improvement, development, and preparation of trending reports for SPC analysis:

• Assist implementation of facility, equipment, and process improvement projects.

• Assist in writing specifications, protocols  and reports related to facility, equipment, andprocess improvement of production process.

• Modification of SOPs and BPR's for new processes  in accordance with change control policies.

• Perform activities involved in IQ, OQ, and PQ for new equipment.

• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates.

• Collaborate with other departments for root cause analysis and assist with implementation of corrective actions.

Minimum Qualifications:

• Minimum three (3) years College Diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) plus a minimum of one (1) year of previous relevant work experience.

• Preferred (4) years bachelor’s degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) plus a minimum of two (2) years of previous relevant work experience.

• Purification Process for viral proteins

• Production Equipment.

• Aseptic Technique.

• Current Good Manufacturing Practices (cGMPs).

• Chemistry, Microbiology, Biochemistry, Mathematics.

• Computer.

• Mechanical Aptitude and Technical Writing.

• Communication/ Networking.

• Interpersonal / Teamwork.

• Stress/Time Management and Conflict Resolution.

• Flexibility/ Adaptability.

Hours Of Work:

• Inclusive from Monday to Friday: 8:00 a.m - 4:00 p.m (subject to change)

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

&anchor=GD-SP #LI-SP