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.
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