Sterility Assurance and Microbiology Specialist – Sterile Site at Sanofi Aventis US LLC

Toronto, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

110100.0

Posted On

07 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sterility Assurance, Microbiology, Contamination Control, Risk Assessment, SOP Management, Investigation, CAPA, Cross-functional Collaboration, Shop Floor Oversight, Data Review, Audits, Regulatory Inspections, Validation Protocol, GMP Knowledge, Documentation Review, Communication

Industry

Pharmaceutical Manufacturing

Description

R2844965 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 Language: Local language and English 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 "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 Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

This role involves leading as a Subject Matter Expert (SME) on contamination control SOPs, conducting related risk assessments, and overseeing site performance for these systems. The specialist will also lead investigations following failures, propose corrective and preventive actions (CAPA), and collaborate with cross-functional teams to ensure product quality.