Sterility Assurance Expert

Sanofi

Le Trait, France
Onsite
Sterility assurance activities coordination
Microbiological control of facilities
Environmental monitoring and trend analysis
Sanofi is seeking a Sterility Assurance Expert for its Le Trait site in France, a strategic location dedicated to producing innovative injectable biologics. The role involves coordinating sterility assurance activities and ensuring compliance with international standards, appealing to candidates with a strong background in microbiology and experience in sterile product production

Job Summary

  • Sanofi Le Trait is a strategic site with over 1,000 employees, producing three blockbuster injectable biological products and serving as a center of excellence for technological development.
  • The role involves coordinating sterility assurance activities, piloting contamination control strategies, supervising environmental monitoring, and conducting aseptic simulations.
  • Join a site undergoing technological and digital transformation, located near Rouen and Paris, offering a stimulating work environment and the chance to impact global health by delivering essential treatments.

Matching Summary

Match Score: 85

Sanofi is seeking a Sterility Assurance Expert for its Le Trait site in France, a strategic location dedicated to producing innovative injectable biologics. The role involves coordinating sterility assurance activities and ensuring compliance with international standards, appealing to candidates with a strong background in microbiology and experience in sterile product production.

Skills & Requirements

Must-have

  • Sterility assurance activities coordination
  • Microbiological control of facilities
  • Environmental monitoring and trend analysis
  • Aseptic practices training
  • Microbiological investigations
  • GMP, GLP, cGMP, FDA, ISO standards

Nice-to-have

  • Risk analysis methodology
  • Root cause identification
  • Continuous improvement
  • Digital transformation
  • Teamwork and collaboration

Key Requirements

  • Bac+5 in microbiology, pharmacy, or engineering
  • Experience in sterile injectable product manufacturing
  • Experience in quality control microbiology
  • Experience in sterility assurance
  • Experience in quality assurance

Work Rights

Not specified

Tailored Resume

Cover Letter