Process Engineer

Key Responsibilities

• Support and execute process and technology transfer activities for sterile drug products.
• Prepare, review, and author GMP-compliant technical documentation and transfer packages.
• Evaluate manufacturing processes, equipment suitability, process performance data, and facility readiness.
• Review deviations, investigations, CAPAs, process risks, and validation evidence to support transfer decisions.
• Collaborate with internal and external stakeholders across manufacturing, quality, validation, regulatory, and supply chain functions.
• Support project planning, action tracking, risk management, and progress reporting.
• Contribute to the successful transfer of products from development through validation and commercial manufacturing.

Required Experience

• 5-10 years of experience in one or more of the following areas:
  • Manufacturing Science & Technology (MSAT)
  • Process Engineering
  • Technical Transfer
  • Process Validation
  • GMP Manufacturing
• Proven experience supporting technology or process transfer projects.
• Experience authoring technical and GMP documentation.
• Strong knowledge of sterile drug product manufacturing.
• Demonstrated expertise in:
  • Aseptic filling operations
  • Freeze-drying (lyophilisation)
• Understanding of the pharmaceutical product lifecycle, including development, validation, regulatory submissions, and commercial supply.
• Experience analysing manufacturing processes, process risks, and validation data.
• Strong communication skills with the ability to engage effectively with international stakeholders.
• Experience working independently and within cross-functional project teams.

Language Requirements

• Fluent French
• Fluent English

Working Arrangement

• Primarily onsite in the Lyon area.
• Travel to manufacturing partners and project locations may be required.
• Full-time commitment is expected, with assignment scope adjusted according to project requirements and transfer activities.