Quality Sterility Assurance and Microbiology Specialist - Vaccines

R2852271 Quality Sterility Assurance and Microbiology Specialist - Vaccines

Location: Toronto, ON

Duration: Fixed term, 1 year

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 

About Sanofi 

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main Responsibilities:

• Leading as SME specific subjects part of the Contamination Control SOP in her/his area of expertise

• Conducting risk assessments related to contamination control

• Overseeing site activities and performance for contamination control systems in her/his scope of responsibilities

• Leading investigation following contamination control failures and propose corrective and preventive actions (CAPA)

• Collaborating with cross-functional teams to ensure product quality

• Ensure presence on the shop floor to oversee practices, identify gaps vs SOP for contamination control

• Reviewing data from contamination control monitoring to propose improvements as necessary (from monitoring and trends)

• Participating in audits and regulatory inspections and audits, providing expertise on sterility assurance and microbiology

• Supporting the preparation of validation protocol and support project related to her/his area of expertise

• Contributing as an SME to specific CoE/CoP with Global functions; implementing on site the best practices shared.

Key Roles:

• Advise on sterility assurance & microbiological protocols and procedures (A)

• Propose corrective and preventive actions to improve contamination controls (D)

• Advise cross-functional teams on best practices or expected improvements in her/his area of expertise (A)

• Presence on the shopfloor with formal traceability of the observations; Inform management and feedback operators (A)

• Contribute to quality documentation SOP and validation protocol.

About You

• Bachelor of Science/Engineering with 2 years previous relevant experience in a Pharmaceutical/Biotechnology laboratory setting or related experience. MSc. is a preferred asset.

• Sound knowledge and experience working in the field of Microbiology or a related field

• Excellent understanding of GMP requirements

• Sound knowledge and experience with Microbiology analytical methods including but not limited to: LAL, Bioburden, Organism Identification

• Sound statistical knowledge

• Strong written and oral communication skills

• Strong analytical and balanced decision-making skills

• Complete work in a timely, accurate manner with minimal supervision

• Ability to work independently as well as part of a team. 

• Organizational skills, flexibility and efficiency are essential

Why Choose Us?  

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs. 

AI Usage

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.