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Manager, Sterilization Validation Maintenance (Vaccine Manufacturing)

Toronto, Canada

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Responsibilities

Manager, Sterilization Validation Maintenance (Vaccine Manufacturing)

Reference #: R2492204

Department: Facilities Management, Metrology

Location: Toronto, Ontario

About Sanofi Pasteur

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

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.

Position Summary:

The major responsibilities of the Manager, Sterilization Validation Maintenance (Vaccine Manufacturing) include the following:

  • Plan, coordinate review, approve and manage the validation project personnel and activities to support Industrial Operations and R&D for Sterilization, Decontamination and Depyrogenation processes for the Technical Services SVM Group. 
  • Provide scientifically sound analysis, discussions and recommendations where required for troubleshooting and investigative roles for all Quality Systems. 
  • Represent Sanofi Pasteur during Regulatory, Corporate or Internal inspections or activities.
  • Act as liaison between validation and production to ensure validation recommendations are implemented.

Key Accountabilities:

  • Manage sterilization validation projects including:
    • Design scientifically sound studies and prepare, review and or approve detailed validation protocols.
    • Coordinate validation activities with a multidisciplinary team with both internal and external personnel as required.
    • Review of raw data for scientific and regulatory accuracy.
    • Prepare, review and or approve validation reports consistent with Sanofi Pasteur policies and acceptable to regulatory agencies. Ensure clarity and correct scientific content in discussions.
  • Coordinate process improvement projects or studies. Perform validation or process improvement experiments or work with system/process owner to perform the validation as per designated protocols.
  • Perform root cause analysis as part of investigations and working with the process owner and subject matter experts.
  • Provide training for execution of protocols and process improvement studies to assist in successful completion of project. Support manufacturing in PC/APC implementation as required.
  • Contribute as a cross functional service provider across Sanofi Pasteur Toronto site; working with competing demands from manufacturing/production, quality, regulatory/regulatory bodies, testing labs, union employees etc.
  • Working with mature systems and technologies to ensure optimization of products and timelines.

Education/Experience:

  • MSc (Science/Engineering) with 5 years GMP or BSc (Science/Engineering) with 7 years GMP experience
  • Strong thermovalidation knowledge of isolator, autoclaves, Freeze dryer (lyopholization) and CIP/SIP

  • Experience with troubleshooting, process improvement and Lean methodology
  • Project management experience and certification is an asset
  • Flexibility to plan and work with rapidly changing business needs and ability to accommodate as a subject matter expert

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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