Sanofi

Sterility Assurance Specialist

In short

This role manages contamination control and sterility assurance at Sanofi's biotech manufacturing site in Vitry-sur-Seine (France), covering monoclonal antibody production. It is posted by a large biopharmaceutical company and involves risk assessments, investigations, Gemba field presence, and representing the site during regulatory audits. It demands prior experience in contamination control, sterility assurance, microbiology or quality assurance in a pharma/biotech production site, a Master's-level scientific degree, and fluency in both French and English.

About the role
As a Contamination Control Specialist within the Sterility Assurance and Contamination Control team at our Vitry-sur-Seine production site, you will be a key player in managing biocontamination risk and will directly contribute to the site's quality and regulatory compliance. Ready to get started?
Join a team committed to manufacturing biotechnology products (monoclonal antibodies) that protect and treat millions of patients around the world. You will help ensure operational excellence and the safety of products manufactured on site.
About Sanofi
Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and create long-term growth. Our deep understanding of the immune system – and our innovative pipeline – allows us to invent medicines and vaccines that treat and protect millions of people worldwide. Together, we chase the miracles of science to improve people's lives.
Main responsibilities
•Be the site's technical referent on contamination control procedures within your area of expertise
•Carry out contamination control risk assessments, notably when introducing new products into the site's production facilities
•Oversee the activities and performance of the site's contamination control systems (controlled atmosphere zones, critical utilities, pest control)
•Lead investigations following contamination control failures and propose corrective and preventive actions
•Ensure field presence (Gemba) to oversee practices, identify deviations from procedures, and provide feedback to operational teams
•Analyze contamination control monitoring data and trends and propose improvement areas
•Represent the site on contamination control during regulatory audits and inspections, and contribute to international expert communities to share and deploy network best practices
About you
Experience:
Proven experience in contamination control, sterility assurance, industrial microbiology, or quality assurance at a pharmaceutical or biotechnology production site is required, ideally including experience with regulatory inspections.
Technical and interpersonal skills:
Solid knowledge of pharmaceutical microbiology and good manufacturing practices, proficiency in risk analysis and management of deviations and corrective/preventive actions, rigor, team spirit, communication skills, leadership.
Education:
Advanced scientific degree (Bac+5 / Master's level) in microbiology, biology, biotechnology, pharmacy, or quality engineering, or equivalent experience.
Languages:
Fluent English
Fluent French required
Why choose us?
•Join a committed team at the Vitry-sur-Seine site, at the heart of activities offering strong visibility into the site's quality and compliance challenges.
•Build your future with the latest tools, digital innovation, and continuous learning to always stay ahead.
•Thrive in a committed company where your voice matters and your work improves the lives of millions of people.
•Flourish in inclusive and flexible environments that support your personal and professional well-being.
•Attractive compensation, along with social benefits.
•Depending on your assigned site, access to a company restaurant with Sanofi's contribution.
Salary range for this position: €48,000.00 - €64,000. Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

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