Description:
Sterility Assurance and Microbiology Specialist – Sterile Site
Location: Toronto, ON (Onsite)
Duration: 18 months
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 Involvement In Decision Making Process
Key roles (D,A,I)
- 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
- Three‑year diploma or bachelor’s degree with 1-2 years of experience.
- Experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment is highly preferred.
- Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with Sanofi GOP / Quality standards
- In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
- Communication skills to communicate with a large number of functions (from shopfloor to management) and to present complex subjects
- Ability to organize and lead routine investigations with a multi-disciplinary team