Sterility Assurance and Microbiology Specialist - Sterile Site

Reference no. R2863206

Position title: Sterility Assurance and Microbiology Specialist - Sterile Site

Department: Sterility Assurance Programs & Site Support

Location: Toronto, ON

Duration:  Fixed Term Contract End Date July 7, 2028

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 subject(s) as 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

Additional Accountabilities:

• Ability to review and interpret data, identify trends, and support data-driven decisions to maintain quality performance and regulatory compliance.

• Clear written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and support interactions with regulatory authorities, as needed.

• Demonstrated problem-solving expertise, including participation in root cause analysis and implementation of corrective and preventive actions.

• Basic project management capabilities to support multiple quality-related initiatives while meeting assigned timelines.

• Follow site and global HSE guidelines

• Support management of environmental monitoring systems by performing administrative and routine maintenance activities as required

• Support end to end deployment of system upgrades (i.e. creation/execution of user acceptance tests)

• Conduct user access reviews, electronic data periodic reviews and data integrity risk assessments for environmental monitoring systems

• Support thedevelopment, execution and maintenance of sterility assurance training modules for cleanroom practices and behaviours, aseptic gowning, microbiology, cleaning & disinfection, environmental sampling, environmental monitoring systems and aseptic operator qualification

• Manage all training documentation in collaboration with Training and Development

• Perform, assess and maintain aseptic operator initial qualification and annual re-qualification program for gowning as part of the aseptic operator quality training program

• Assess and perform the required training/re-training as assigned through environmental monitoring investigations, sterility assurance surveillance program, regulatory responses, CAPA actions as applicable

• Prepare inspection readiness packages as related to sterility assurance training program and environmental monitoring systems

• Perform sterility assurance related change control requests, CAPA’s, EC’s

• Participate as a quality representative in sterility assurance continuous improvements and strategic site projects

• Assess and/or approve Sterility Assurance related Change Control/CAPA requests

• Additional duties as required

About You
Qualifications:

• Bachelor of Science degree in a scientific or related technical discipline, with a strong preference for Microbiology.

• Approximately 2-3 years of experience working within a GMP-regulated environment.

• Exposure to sterile manufacturing or contamination control or equivalent is preferred.

• Fluency in English, both written and spoken.

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. 

This position is for a current vacant role that we are actively hiring for.​ 

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.