Technical Group Leader, B89 Media- Vaccines

Reference No. R2742303

Position Title: Technical Group Leader, B89 Media- Vaccines

Duration: Fixed-Term Contract End Date: May 28, 2027

Department: cP MWS

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

• Schedule and coordinate daily/weekly work of a group of technical staff in the Media, Washing and Sterilization area.
  
• Check and review Records, SOP, logbooks, and monitoring charts for completion and insurance of accuracy of all documents as per GMP guidelines.
  
• Ensure equipment is kept in good GMP condition (with preventive maintenance, validation and certification).
  
• Order and ensure adequate chemicals, supplies, and spare parts for equipment. Facilitate daily meetings and report findings to management.
  
• File quality notifications and participate in lead investigations.
  
• Coordinate with units within department (Upstream and Downstream) and other outside departments (maintenance, washing and sterilization, media, QO test labs) and ensure timely completion of production support activities.
  

• Ensure operators are equipped and use proper PPE when performing tasks. Drive culture of HSE in department.
  
• Ensure operations are performed in an ergonomic way and escalate any potential hazards. Help develop proposed solutions.
  
• Ensure routine HSE checks and inspections are completed and in timely manner.
  
• Promote waste and environmental awareness using 3Rs (Reduce, Reuse, Recycle)
  
• Ensure chemicals are stored as per HSE requirement and has MSDS available.
  

• Perform accurate formulation calculation and measurements of weigh and volume and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
  
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
  
• Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
  
• Provide guidance to technical staff on problem solving and trouble shooting. Ensure area is inspection ready. Knowledgeable to guide inspectors.
  

• Coordinate and oversee technical staff completion in SAP activities.
  
• Capacity planning, budgeting and scheduling of materials and personnel (MPS,
  
• MRP).
  
• Create maintain process orders with authorization to change orders upon demand.
  
• Ensure transactions are done on a timely, accurate manner.
  
• Confirm inspection characteristics for batches, perform Stock Posting when needed.
  
• Ensure all data input is completed accurately and in timely manner such as Shop Floor Data, LI Ms, Master, change request forms.
  

• Coordinate and schedule work of technical staff in facility, equipment, and process improvement projects with Manufacturing Technology (MTech) and facility management (Global Engineering Maintenance).
  
• Assist implementation of facility, equipment, and process improvement projects.
  
• Write specifications, protocols and reports related to facility, equipment, and process improvement of production process.
  
• Modification of SOPs and BPRs for new processes in accordance with change control policies.
  
• Perform IQ, OQ, and PQ for new equipment.
  
• Attend meetings with other support functions representing production as needed.
  

• Monitor and analyze production process and test data, launch investigation for out of trend, alert management and Manufacturing Technology.
  
• Maintain test result and process database, assist in preparation of root cause SPC analysis reports.
  
• Collaborate with other department functions (QO, MTech) for root cause analysis and present findings.
  
• Initiate CCR, CAPA as needed and manage them til completion as per committed due dates.
  

• Ensure production area is kept in a tidy, GMP manner, following 5 S guideline (sort, straighten, shine, standardize, sustain)
  
• Disinfect area as required in SOP.
  
• Coordinate with various team members to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
  
• Propose to management ways of improvement.
  

• Minimum four (4) years bachelor's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of four (4) years previous relevant work experience.
  
• Preferred two (2) years master's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of three (3) years previous relevant work experience.
  
• Sound Knowledge of Microbiology.
  
• Sound knowledge of protein purification.
  
• Aseptic Techniques
  
• Chemistry, Mathematics.
  
• cGMP, cGLP.
  
• Problem solving, trouble shooting, technical writing, leadership, stress and time management skills.
  
• Computer skills, SAP, Visio, Autocad, MS Access, JMP.
  

• Inclusive from Monday-Friday 6:00 am - 2:00 pm.