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Lead, Cleaning and Support Processes Validation (new vaccine manufacturing facility: B100)

Toronto, Canada

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Responsibilities

Lead, Cleaning and Support Process Validation (new vaccine manufacturing facility: B100)

Reference #: R2494661

Department: B100 MTech

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 Cleaning and Support Processes Lead will report directly to the B100 MTech Leader, with the following key accountabilities:

  • Lead the cleaning validation team to support C&Q of cleaning systems.  
  • Deliver a strong and comprehensive validation program and package for cleaning, media/buffer preparation, adjuvant manufacturing and extractables and leachables for single-use applications.
  • Lead/Support commissioning and qualification of media and buffer preparation and delivery systems.
  • Ensure robust and consistent cleaning/media/buffer processes.

Position Accountabilities:

Single-Use Technology (Technical Direction and Leadership):

  • Lead evaluation/suitability of use for SUT solutions (e.g. filters, tubing, connectors, containers, bags, etc) for acellular Pertussis, Diphtheria and Tetanus processes
  • Drive the Extractables and Leachables plan and studies.

Cleaning Validation expertise (Technical Direction and Leadership):

  • Oversee/prepare cleaning validation master plan. 
  • Drive cleaning validation strategy and program (e.g. residue ID, equipment characterization and bracketing/grouping, worst case soil identification, cycle development, clean /dirty hold times, etc).
  • Lead cleaning validation team in the execution of cleaning cycle development and validation, to secure robust and effective cleaning processes.
  • Ensure preparation, review and approval of protocols and reports as per project schedule.

Media and Buffer Process Validation expertise (Technical Direction and Leadership):

  • Provide technical risk assessments and gap analysis.
  • Oversee/prepare Media and Buffer process validation master plan.
  • Drive/Lead execution of validation of buffer and media preparation processes, ensuring preparation, review and approval of protocols and reports as per project schedule.
  • Commissioning and Qualification of Cleaning Systems.
  • Working closely with C&Q, Automation and Process Engineering leads to support assessment of system integration, flow path sequencing, and recipe development.
  • Support development and execution tests for SAT and Qualification of CIP skids and their target systems.

Education and Experience:

  • Minimum MSc, PhD preferred.
  • Minimum 8 (eight) years direct process validation experience in biotech pharma/biotech manufacturing and quality environments.
  • Minimum 5 (five) years demonstrated leadership in behavioral competencies and management.
  • Strong experience and expertise in process validation, which includes cleaning validation, media and  buffer validation and filter validation.
  • Direct application experience in industrial process equipment that includes CIP Systems, In-Line Dilution Skids and Buffer and Media Preparation systems with knowledge in sanitary design and ASME BPE standards.

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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