Sterility Assurance and Microbiology Specialist - Sterile Site

Sanofi•Toronto, ON

1d•CA$69,200 - CA$100,000•Onsite

About The Position

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. Sanofi is 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.

Requirements

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.
Fluency in English, both written and spoken.

Nice To Haves

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

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
Advise on sterility assurance & microbiological protocols and procedures
Propose corrective and preventive actions to improve contamination controls
Advise cross-functional teams on best practices or expected improvements in her/his area of expertise
Presence on the shopfloor with formal traceability of the observations; Inform management and feedback operators
Contribute to quality documentation SOP and validation protocol
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 the development, 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