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Sanofi Group Manager Aseptic Performance and Monitoring - Vaccine in Swiftwater, Pennsylvania

Manager Aseptic Performance and Monitoring – Entry Level

Location: Swiftwater, PA

This position will represent Aseptic Performance and Monitoring by performing airborne particulate data approval, coordinating and/or attending routine meetings, spending time on the shop floor, and providing guidance and assistance to the site as related to Environmental Monitoring, Traffic and Gowning and Cleaning/ Disinfecting programs and practices.

Key Accountabilities:

  • This position will support the Environmental Monitoring group within the Aseptic Performance and Monitoring (APM) organization

  • This individual will have knowledge of and support the EM programs, for Antigen, FFIP and projects.

  • Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen or formulation production).

  • Individual may be responsible for direct hands on shop floor support tasks including (not limited to): audits, GEMBA support, oversight for aseptic processes, etc..

  • The individual will also facilitate system improvements as assigned by APM Senior Management.

  • The individual may also author departmental documents (protocols, reports, procedures, etc.), lead, manage, and author investigation reports, change controls, and APM specific studies as required and assigned.

  • Excellent communication skills and teamwork are a must, as individual will be working cross functionally. The individual must have the skills and the ability to perform training which are essential skills needed to be successful in this role. Employee will also need a strong customer focus with an ability to prioritize and adapt to the business needs.

Basic Qualifications:

  • Bachelor’s degree in Engineering, Science or related field. 4+ years of experience in a Quality role will be evaluated in lieu of a degree.

  • 0-2 years’ experience in a cGMP controlled/ pharmaceutical industry including prior knowledge of cGMPs and regulatory requirements, contamination control, disinfection, sterility assurance, aseptic processing.

  • Preferred prior knowledge with computer systems such as Phenix (CCR, deviation, CAPA), Geode+, MS Office (Word and Excel), MASTER, PharmNet-Web, JMP.

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.

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