Quality Control Maintenance and Qualification Specialist

R2872437 Quality Control Maintenance and Qualification Specialist

Location: Toronto, ON

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.

Our Team / Overview:

The Quality Control Team is part of Site Quality Operations supporting the Manufacturing & Supply organization in Toronto. The Quality Control team oversees analytical testing, product release, method validation, stability programs, and laboratory operations in alignment with regulatory requirements and Sanofi standards. The team drives continuous improvement and operational excellence initiatives to enhance laboratory efficiency, analytical capabilities, and quality systems performance.

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:

Executing the maintenance and qualification protocols in their area

Writing or reviewing the maintenance and qualification documentation, when not executing; this includes protocols, reports, risk assessments, and traceability matrices according to predefined timelines

Informing their manager of any quality or HSE event related to lab equipment in a timely manner to ensure investigation and impact assessment are performed appropriately

Ensuring proper documentation of deviations, non-conformances, and corrective actions

Ensuring proper evaluation (validation expertise) of change controls related to his/her scope

Ensuring all maintenance and qualification activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards

Cooperating with cross-functional teams, including engineering and external suppliers, to ensure smooth execution of validation activities

Identifying opportunities for improving maintenance and qualification processes and contributing to continuous improvement initiatives

Performing routine and preventive maintenance and qualification on equipment and systems to ensure optimal performance and reliability

Troubleshooting and repairing equipment and systems as needed to minimize downtime and ensure continuous operation

Maintaining accurate records of maintenance and qualification activities, including work orders, maintenance logs, and calibration records

 Key Involvement in Decision-Making Process

Execute or coordinate the maintenance and qualification plans for the lab equipment

Responsible for performing routine and preventive maintenance and qualification on equipment and systems

About you

A Bachelor of Science, Engineering, or related field

1 year of experience in qualification activities within the pharmaceutical or biotechnology industry

1 year of experience in quality control

Proficiency in preparing maintenance and qualification documentation

Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to qualification

Ability to manage multiple qualification projects simultaneously, ensuring they are completed on time and within budget

Excellent communication skills to effectively collaborate with cross-functional teams.

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.

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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.