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Operations Manager - Media, Washing and Sterilizing- Vaccines

AT Sanofi U.S.
Sanofi U.S.

Operations Manager - Media, Washing and Sterilizing- Vaccines

Canada

Reference No. R2772781

Position Title: Operations Manager - Media, Washing and Sterilizing- Vaccines

Department: B200 Operations - Buffers, MWS & Logistics

Location: Toronto, ON

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The B200 MWS Manager is responsible for manufacturing operations in the Buffer Preparation, Washing & Sterilizing, and Raw Materials areas of Building 200. The manager is responsible for the daily acitivities of unionized staff in a cGMP facility in compliance with company policies. This includes responsibility for the scheduling and execution of all operations with adequate level of GMP documentation. This also includes active involvement in B200 project activities, from design to commercial operations.

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We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Technical 20%
  • Participate in the design, commissioning, startup, and troubleshooting of MWS processes (Raw Material receipt/handling/storage, Weighing & Dispensing, Buffer Preparation, Decontamination, Washing & Sterilizing) and equipment operations through all stages of project (C&Q, IQ/OQ, Engineering and Consistency runs, full operations)
  • Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up
  • Review and approve technical and quality related documentation (P&ID, IOQ, PPQ, and design documents)
  • Provide troubleshooting and problem-solving guidance for daily project and manufacturing issues, and implement preventative/corrective actions
  • Participate in and support the incorporation of digital technology (e.g., electronic batch records and e-logbooks) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability

Planning and Execution 25%
  • Develop and execute production schedules from project through full scale manufacturing, ensuring that project support and production activities are executed as per defined schedules
  • Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor and communicate team and project performance with respect to deliverables using visible metrics.
  • Support development of operating budget and staffing for operations and project related activities from design to start-up
  • Develop communication approach for operations topics to ensure project milestones are met (e.g., escalation, cascading)

cGMP Compliance & Quality 20%
  • In collaboration with OQ, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge.
  • Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner.
  • Through appropriate shop floor oversight, ensure that facilities & equipment are compliant, and that process and environmental deviations are addressed in an expedited and compliant manner.
  • Support internal and external regulatory audits/inspections and coordinate appropriate responses

People and Development 20%
  • Organize and develop staff to ensure a high performing team. Provide individual feedback on staff objectives and development, coaching each team member on personal development milestones.
  • Contribute to the B200 Operations management team, communicate and co-operate cross-functionally to achieve project and operational goals.
  • Hire and on-board new employees, manage team attendance and performance.
  • Develop and oversee technical training plan to ensure training compliance for all shop-floor staff

Continuous Improvement 10%
  • Implement lean management systems and continuous improvement of processes established for IA.
  • Challenge status quo: identify and lead initiatives to increase process efficiency, quality, and/or yield.
  • Implement solutions or changes via change control, plan and manage facility and organization improvements
  • Provide metrics and other reports as requested, including the scheduling of PM plans, spare parts, BOMs

Safety 5%
  • Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents; critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified and known by staff and that protective equipment and clothing are required and are used; continuous HSE awareness and improvement by integrating team with site and Bulk initiatives
  • Cooperation with and assistance to the HSE management and Joint Health and Safety Committee in carrying out their functions
  • Ensure complete and comprehensive safety training of staff
  • Must have full understanding of all Hazard and Operability Analysis (HAZOP) and awareness of all Hazard Identification (HAZID) pertaining to Operations equipment and processes

Scope and dimensions

  • Shift size: 10-20 Union staff
  • Oversees Media, Washing, & Sterilizing operations in Building 200 on the Afternoon Shift
  • Provides support to Upstream/Downstream operations when required
  • Develop and ensure consistency of communication across shifts
  • 10% travel to international company sites and to both domestic and international equipment manufacturers may be required

About You

Education and Experience
  • Minimum BSc in Microbiology/Biochemistry/Engineering or Related Science(s)
  • At least 5 years of experience in pharmaceutical industry/manufacturing (people management experience preferred)
  • Business and/or management training would be an asset
  • Experienced with manufacturing automation (e.g., DeltaV) and/or electronic batch records would be an asset

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

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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Client-provided location(s): Canada
Job ID: Sanofi-https://jobs.sanofi.com/en/job/toronto/operations-manager-media-washing-and-sterilizing-vaccines/2649/19152142016
Employment Type: Other