Manager Quality Validation Job at Quality at SanofiLocation Swiftwater, Pennsylvania Job Category Quality Requisition Number POS_00406607-1
Who We Are
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
To provide Quality & Compliance oversight to site qualification / validation projects related to aseptic filling using RABS and isolator technologies, lyophilization processes.
Ensure site policies and regulatory requirements are followed for projects involving qualification and validation of equipment, facilities and utilities, aseptic filling and lyophilization processes, and Visual Inspection (Automated and Manual) processes.
Participate in project teams and review and approve qualification and validation related documentation for assigned areas including Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs, PQ and PV.
This position has signatory responsibilities for all qualifications/validation issues associated with assigned areas.
Who You Are
You are inspired and driven by sanofi pasteur’s IO mission to improve worldwide human health. You would fit in well with our sanofi values of innovation, solidarity, confidence, respect and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
Education and experience
Key technical competencies:
Must have an understanding of vaccines/biologics products and associated technologies, sterility assurance and associated technics
Experience with qualification of Automated and Manual Visual Inspection Processes is preferred
Working knowledge of cGMPs
Industry validation practices related to aseptic filling using RABS and isolator technology and lyophilization
Qualification and Validation of process equipment and systems including syringe or vial filling equipment, lyophilizers and Restricted Access Barrier Systems (RABS) and/or isolators
Experience with aseptic processing
The ability to work on cross-functional teams
Experience with Qualification of Visual Inspection Processes (Automated and Manual) is preferred
Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
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.
Bachelor's Degree in field of Science, Technology or Manufacturing
3+ years’ experience in a GMP regulated environment working on qualification and validation of aseptic filling processes using RABS and isolator technology, lyophilization, and equipment.
Job : Quality
Primary Location : United States-Pennsylvania-Swiftwater
Job Posting : Jun 13, 2016, 9:14:42 AM
Job Type : Regular
Employee Status : Regular