Careers

North York, Ontario

Process Validation Engineer

Validation Engineer I

North York

Duties: 

  • The Process Validation Specialist will report to the B100 MTech Upstream Lead, with the following key accountabilities:
  • Coordinate and execute fermentation and microfiltration process development and optimization for Component Pertussis, Diphtheria, and Tetanus
  • Test and develop protocols for use of Process Analytical Technologies (PAT) for use in B100
  • Perform single-use technology assessment studies
  • Deliver a strong and comprehensive characterization and validation package in collaboration with the Mtech B100 team and other key players (ARD, AP&T, BRD, QC, etc)
  • Support the qualification of upstream process equipment to ensure full compliance to process specifications/ requirements, industry standards and quality aspects
  1. 40% Deliver on Design and Qualification Phases
  • Review process flow diagrams, mass balances and process descriptions and process assessments/impacts including critical parameters
  • Participate in Functional Component Criticality Assessment for process equipment to ensure alignment with process requirements and specifications
  • Assess new technology implementations, including closed system, PAT, and single-use technology
  • Support C&Q activities: including (but not limited to) SAT, IQ, and OQ of the applicable process equipment/systems in conjunction GEM, Operations and Quality/validation
  1. 40% Upstream Process Development, Optimization and Validation
  • Oversee design and execution of scale-down of manufacturing processes to support validation and characterization. Demonstrate adequacy of the solutions selected with the process needs. Collect and properly interpret data generated from execution of studies.
  • Perform process development and validation with industrial equipment, that includes isolators, fermenters, centrifuges, and microfiltration systems
  • Execute process validation studies, developing detailed validation and study protocols/reports related to process, cleaning, decontamination, and related supportive studies. Ensure documentation is compliant with Sanofi Pasteur policies and regulatory expectations. Take accountability for technical accuracy.
  • Contribute to troubleshooting and root cause analysis
  1. 20% Transversal Support
  • Assist in sample and material management during engineering, technical and consistency batches
  • Provide training on operation/use of process equipment (within areas of equipment specialization)
  • Ensure process knowledge transfer throughout all phases of project execution up to and including consistency lots and regulatory preparation
  • Provide technical advice and guidance to the upstream team

Skills:

  • Minimum 3 years direct experience in biotech R&D, manufacturing, and quality environments/ organizations. This includes hands-on experience with fermentors, centrifuges, filtration systems, and single-use technology
  • Demonstrated technical competencies in biopharma or life science industry
  • Sound knowledge in fermentation and harvest techniques is a must.
  • Experience in process industrialization is an asset but not required
  • Demonstrated understanding of current Good Manufacturing Practices – a high nice to have
  • Equipment and process validation experience
  • Excellent verbal and written communication skills
  • Strong technical writing is essential

 

Education:          

B.Sc. or M.Sc. with an Engineering background preferred, in Biochemistry or related field