R2862433 Quality Sterility Assurance and Microbiology Specialist Location: Toronto, ON Duration: Fixed Term, December 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: Sterility Assurance and Microbiology Control PCU Specialist is responsible for the Sterility Assurance of the manufacturing processes, processing areas and product through implemented site wide compliance programs managed by the team 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 Follow site and global HSE guidelines Provide oversight and technical direction EM, Contamination Control and Utility Sampling programs Ensure timely review, approval of Critical Utility and Environmental Monitoring trend reports for area(s) of responsibility Provide oversight and technical direction associated with execution of APSS, EM area qualification and ISO certification Review and approve applicable departmental flow and engineering diagrams as needed Provide Quality decisions and assessments to support shopfoor/ investigations, as related to Sterility Assurance Programs. Perform sterility assurance related Change Control Requests, CAPAs Acts as a Change Control Sterility Assurance assessor and CAPA QA expert Provide technical training on contamination control, as required Participate, as a Quality representative, on facility, environmental and sterility assurance continuous improvements and strategic Site projects Leads Sterility Assurance continuous improvements for the APU and acts as a Quality representative on APU / Site strategic projects as it pertains to Sterility Assurance. Additional duties as required Abou 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 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 new vacant role that is now open for applications. AI Usage "Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. #GD-SP #LI-SP #LI-Onsite Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! North America Applicants Only The salary range for this position is: 76,200.00 - 110,100.00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK. La fourchette salariale pour ce poste est la suivante: 76,200.00 - 110,100.00 La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.