Technical Manager – Filling, Filling and Inspection - Vaccines

Job Identification

Position Name: Technical Manager – Filling, Filling & Inspection

Family: Production > Fill

Site/Department: TORONTO / FF&P

Job Posting Dates: Friday January 17,2025

Job Posting Expires: Friday January 31,2025

Mission

The purpose of the Technical Filling Manager is to ensure the production process she/he is responsible for successfully meets the supply chain requirements of Sanofi Pasteur. 

The Technical Filling Manager is successful by considering various aspects of safety, quality, compliance, efficiency and teamwork to approach both production schedules and production challenges.  The manager is successful by working with/ensuring a staff of trained, empowered aseptic manufacturing experts.

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.​

Safety:

• 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 EHS awareness and improvement by integrating team with site initiatives
• Conduct duties in a safe manner and report all safety issues or concerns
• Work with Sanofi safety personnel, respond to internal safety audits/observation
• Co-operate with and provide assistance to the EHS management and Joint Health and Safety Committee in carrying out their functions.

cGMP Compliance & Quality:

• Promote a quality mindset and quality excellence approach to all activities
• Ensure environmental control and microbiology contamination control programs comply with applicable regulatory standards for Filling and Inspection process
• Develop and lead EM/microbiology/contamination control programs
• Lead and maintain aseptic training program and sterility assurance/contamination control risk assessments
• Support with Disinfectant Efficacy Studies, Environmental Monitoring Trend Reports,
• Perform EU Annex-1 gap analysis and close them.
• Maintenance of SOP’s accurately describing production equipment, procedures and processes.
• Maintenance of BPR’s to document the manufacture of product in the aseptic processing areas.
• Recommend action and continuous improvement plans
• Management of CAPAs and Change controls for Filling and Inspection
• Observance of various quality systems for data management, document authoring, document approvals, equipment/facility monitoring, quality notifications, quarantines, equipment/facility maintenance, equipment/process/facility change, validations, certifications, and qualifications
• Compliance with cGMP and Standard Operating Procedures at all times
• Provide satisfactory response (verbal and written) during internal or external audits
• Maintain the compliant status of the aseptic processing area in the face of escalating quality standards

Production Support and Execution:

• Maintain recipes for manufacturing processes that define the required time, component/material, equipment, facility and personnel resources to process productions orders.
• Develop programs and train personnel on the importance of microbiological and contamination control

• Oversee/assist in problem solving to overcome short-term problems to meet production schedule, including equipment malfunction, conflict resolution, resource shortages.
• Assist with company projects/initiatives outside of filling and packaging process.  Global initiatives to standardize processes and Quality initiatives.
• Maintenance programs for manufacturing equipment/processes to maximize equipment/process efficiency and utilization.
• Implement/source equipment and resources required for production
• Support validation requirements to maintain production

Technical:

• Provide technical guidance and function as Subject Matter Expert to assist with deviations and/or product complaints related to aseptic filling processes, visual inspection, contamination control etc
• Identify, track and facilitate resolution of Microbiological technical issues

People and Development:

• Effective interaction with other departments (internal and external). In particular, close contact maintained with the Microbiology, Production, Validation, Technical services, Planning Departments & OQ teams
• 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 F&P management team, communicate and co-operate with other departments to obtain consensus and achieve project and operational goals.
• Representing aseptic filling process at cross-functional meetings when requested
• Hire and on-board new employees, apply company’s discipline procedures when applicable, manage team attendance and performance against established criteria.

Continuous Improvement:

• Implement lean management systems and continuous improvement of processes established for Aseptic filling and inspection
• Track, trend, and analyze EM and microbiology testing data for Aseptic filling processes
• 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.
• Provides metrics and other reports as requested, including the scheduling of PM plans, spare parts, BOMS.
• Continuous Improvement (CI) Specialist for Fill Finish Ecosystem supporting SMS2.0

Breadth of responsibility (global/regional/country/site):

• All work performed in the Filling and Packaging Department is time sensitive because the product is at its highest value and is closest to the customer. Any error/delays will result in missing orders to the customer. Missing orders have a negative impact on the company and our business. Failure to meet manufacturing schedules impacts on-time customer delivery.

Key dimensions: Headcount (direct and indirect) budget, doses, Capex

• Supporting 5 day per week operation (and occasional weekend) to meet a demanding production schedule, while exceeding the increasing requirements for quality and safety, which requires a great degree of flexibility and creativity.
• Strong autonomy required
• This position independently supports all production activities in the assigned product/process area.  Under minimal guidance, provides analysis and recommendations to management on all operations related matters.  Decisions must be made in a dynamic setting taking into account and balancing a changing business environment, business priorities, product and process deadlines, and compliance issues.  Must address internal and external regulatory requirement

• Bachelor of Science Degree in Microbiology/Biochemistry/Engineering or Related Science
• 5 Plus years of experience in a Biological or Pharmaceutical industry preferably in aseptic processes, quality operations, project management
• Ability to lead a team handling high value and time sensitive products. Must be a strong leader.
• Effective communication skills, conflict management and multi-tasking skills
• Knowledge of Excel, Word, etc.

Competencies – key competencies the job holder will be evaluated on: Results driven, Customer focused, Teamwork, Innovative thinking

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 and at least 14 weeks’ gender-neutral parental leave.

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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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