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Vaccine Filling and Inspection Professional (Vaccine Manufacturing)

Toronto, Canada

Sanofi, in the U.S. and Canada, strives to create a diverse and inclusive work environment that empowers employees to drive their careers and be successful. The talent we look for will contribute to the organization in innovative, insightful, and creative ways in order to strengthen our dynamic culture and drive us collectively to make a difference in the lives of patients.

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Responsibilities

Vaccine Filling and Inspection Professional  (Vaccine Manufacturing)

Reference #: R2490337

Department: Filling and Packaging

Location: North York, 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.

Job Summary:

This role will manage projects affecting the Filling and Examining platform in relation to process maintenance, compliance and continuous improvement projects. This role will also act as a technical resource person who uses pharmaceutical machine process knowledge to work within Sanofi manufacturing and Quality Systems to support Filling and Examining in the context of operation reliability, change control lead, CAPA owner, lead investigator, SME for global projects, and regulatory audits.  This role will be a SME for both manual and automated examination/vision systems of vaccine product.

Key Accountabilities:

Production Support

  • Support the visual inspection program: coordinate policy and SOP updates and implementation; provide and conduct staff training; review MTech process control charts and reports.  Manage maintenance and tuning of automated/machine vision systems.
  • Coordinate Preventative Maintenance service visits: by working with OEM vendors to review status of machines, communicate and serve as liaison between Filling and Examining scheduling, Technical Services and maintenance vendors; work with shift managers and Mechanic group leader to ensure successful completion of the service visit.
  • Serve as coordinator with other service provider departments, such as, Metrology, Facilities, External vendors, etc., and support the shift managers with operational activities (ex. Annual instrument calibration, etc).
  • Assist in routine re-validation/non-routine validation activities such as autoclave re-validation, smoke studies, ISO Re-Certification etc. with QOVS, Thermal, QOSA. Review and approve related protocols and reports.
  • FFaST Discard Rate Lead: Conduct ad-hoc discussion forum for discard rate trends, events, improvements that can help improve scrap rate. Review and approve discard rate trend reports. Coordinate with Quality to implement CAPA and GQD updates to area specific tasks.
  • Develop training plan for new and existing Filling and Examining employees to ensure all operators are qualified for required job tasks.
  • Hold training sessions to ensure operators understand changes to existing procedures as well as the implementation of new procedures, and to field clarifying questions or concerns from staff.
  • Role of system administrator for various production stand-alone equipment.
  • Support the Filling, Examining and Washing & Sterilizing production operations as necessary by providing guidance/knowledge on cleanrooms, aseptic processing, company procedures.

Quality/ Project Management Support

  • Provide project management support on compliance related activities and continuous improvement projects specific to Filling and Examining, with the aim to close gaps within the required timeframe and ensure minimal impact to production activities.
  • Filling and Examining representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.
  • Perform and/or participate in GQD gap analysis for the Filling and Examining Department.
  • Implements Corrective and Preventative Actions established as Filling and Examining commitments in response to Internal/ Global or Regulatory Audits.
  • Identify opportunities for alignment across the IO platforms or within Filling and Examining, applying LEAN methodologies.

Change Control Lead

  • Initiate and manage change control requests affecting the Filling and Examining Department.
  • Support Lead Investigators and Filling and Examining Platforms in establishing change controls approved for execution in a to support closure of Quality Notifications and cycles of continual process improvement.

Technical Writing

  • Prepare and update GMP documents such as SOPs, SWIs, protocols, and reports.
  • Participate/oversee implementation of component specification documents.

Lead Investigator as assigned

  • Lead Investigator to collect data, investigate and draft report for Quality Notifications affecting the Filling and Examining platforms.
  • Collaborate transversally (QO, TS, MTECH, SME, QC etc.) to support the investigation.
  • In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause.

Education, Experience and Skills:

  • Min Bachelor’s degree in Engineering  or Science
  • 2 years of work experience in a regulated environment (GMP /pharma /biopharm )
  • Excellent computer skills are required with ability to learn new technologies and adapt to new tools.
  • Strong computer systems, machinery/equipment design and operation knowledge.
  • Strong interpersonal skills and the ability to articulate info and technical knowledge within a cross-functional team and to other areas of the business

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.

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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