Sanofi Group Manager Sterility Assurance in Swiftwater, Pennsylvania

Sterility Assurance Manager

Swiftwater, PA- This position will represent FFIP Sterility Assurance by coordinating and/or attending routine meetings, spending time on the shop floor, providing supervision and support to SA non-exempt team, providing guidance and assistance to the FFIP Factory on SA programs and practices.

Key Accountabilities:

*This position will support the Sterility Assurance (SA) FFIP Support group within the Sterility Assurance organization.

*The individual will be responsible for programs and processes within Sterility Assurance Environmental Monitoring process and/or Clean Utilities in support of the FFIP Factory.

*This individual will have knowledge of and support the SA APS program, Cleaning & Disinfection program, Environmental Monitoring, EMPQ, and Traffic & Gowning program in support of the FFIP Factory.

*This employee will independently author, assess, revise, review and approve standard operational documents, reports, protocols, deviation/investigation reports, CAPAs, change control requests, logbooks, etc.

*He/She may be responsible for direct hands on daily SA shop floor support tasks including (not limited to): review of room parameter data, environmental monitoring associated with the surveillance monitoring program, surveillance audits, environmental monitoring training (including program training, sampling method training, use of sampling equipment and database training). This individual will have knowledge of and also support SA Clean Utilities activities, APS activities, Cleaning & Disinfection activities and Traffic & Gowning activities.

*The individual will also represent SA FFIP by providing direct support to internal, corporate, and federal regulatory inspections, by providing pertinent information and material directly to the inspection team.

*The individual will also facilitate system improvements as assigned by SA Senior Management as well as potentially being called as a subject matter expert when the site is under inspection or audit. Excellent communication skills and the ability to perform training are essential skills needed to be successful in this role. You will also need a strong customer focus with an ability to prioritize and adapt to the business needs.

*The individual will also complete tasks as assigned by SA Senior Management.

Key technical competencies and soft skills:

*Must have an understanding of vaccines/biologics products and associated technologies, sterility assurance and associated techniques.

*Must have the ability to aseptically gown.

*Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

Basic Qualifications:

*Bachelor's Degree in life sciences or equivalent.

*A minimum 5 years’ experience in a cGMP controlled/ pharmaceutical industry.

*3-5 years’ experience/knowledge of: cGMPs and regulatory requirements, contamination control, disinfection, sterility assurance, aseptic processing.

*2-4 years’ experience with computer systems such as TrackWise systems (CCR, Deviation, CAPA), eDoc, BlueCielio, MS Office (Word and Excel).

Sanofi Pasteur SA 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.

#LI-SP

#GD-SP

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life