COMPLETE Senior Manufacturing Compliance Engineer - Framingham, MA

Department Description

Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.

Senior Manufacturing Compliance Engineer uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.

Core Responsibilities

• Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.

• Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.

• Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.

• Conducts complex document revisions and /or document management including batch production records, manufacturing procedures, and cross functional procedures.

• Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory and compliance.

• Trains new Manufacturing Compliance Engineers.

• Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.

• Works independently with minimal supervision and direction.

• Participates in determining objectives of assignment.

• Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion.

• Effectively utilizes Microsoft office applications.

• Creates and presents trending and metrics reports.

• Provides direction to the Manufacturing Compliance Engineers in the absence of the operations manager.

• Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget.

• Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services.

• Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results.

• Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues.

*Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services.  This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi's a great place to work and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs

Basic Qualifications

• Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 3-4 years in a cGXP manufacturing environment or a master’s degree in Sciences, Technical, Engineering or Advanced degree and 2 years of experience in cGXP manufacturing environment.

• Knowledge and understanding of Manfacturing.

• Knowledge of GXP regulations and guidance.

• Minimum of 2 years' experience with deviation management systems (e.g. Trackwise, Viva).

• Excellent critical thinking and technical writing

• Excellent written and oral English language skills.

• Proficient with change control requests, CAPAs and deviation quality systems

• Proficient in critical thinking and technical writing

• Experience leading cross functional teams and facilitating team meetings.

• Ability to influence in a cross-functional environment.

• Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents.

• Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects.

• Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time.

• Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery.

Special Working Conditions

• Ability to gown and gain entry to manufacturing areas.

• Ability to work off shift hours, seldom, to support product release.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.