Senior Process Engineer
About the Role
A leading pharmaceutical organisation in Twente is preparing to launch a new aseptic manufacturing project, moving from early development toward clinical readiness over the next few years. To support this growth, the site is seeking an experienced Senior Process Engineer with deep expertise in GMP, aseptic processing, and injectable drug product manufacturing. This is a full‑time, on‑site position within a high‑impact team driving process design, optimisation, and readiness for clinical-stage production.
Key Responsibilities
- Lead process engineering activities for aseptic and sterile manufacturing operations, ensuring compliance with EU GMP and relevant regulatory expectations.
- Develop, optimise, and validate processes for injectable drug products, including formulation, filtration, filling, and lyophilisation (if applicable).
- Support scale‑up activities as the project transitions from development to clinical manufacturing.
- Own process documentation, risk assessments, process flow diagrams, and equipment specifications.
- Collaborate closely with QA, QC, MSAT, Production, and Validation teams to ensure robust, compliant, and efficient processes.
- Drive equipment selection, commissioning, qualification, and troubleshooting for aseptic systems.
- Lead investigations, CAPAs, and continuous improvement initiatives related to sterile operations.
- Provide technical leadership during audits, inspections, and regulatory interactions.
- Contribute to project planning and execution as the programme progresses toward clinical stage in the coming years.
Required Experience
- Strong background in aseptic processing, sterile manufacturing, and injectable drug product operations (must‑have).
- Minimum 5-8 years of experience in a GMP pharmaceutical or biotech environment.
- Proven track record in process engineering, process development, or MSAT within sterile/aseptic settings.
- Experience with equipment and technologies such as isolators, RABS, filling lines, sterilisation, filtration, and clean utilities.
- Solid understanding of EU GMP, Annex 1, and regulatory expectations for sterile product manufacturing.
- Demonstrated ability to lead cross‑functional technical activities in a fast‑moving project environment.
- Strong problem‑solving skills and ability to work hands‑on on the shop floor.
Preferred Qualifications
- Experience supporting projects moving from development into clinical manufacturing.
- Background in tech transfer, scale‑up, or facility start‑up.
- Engineering degree (Chemical, Process, Biotech, or related field).
What This Opportunity Offers
- A pivotal role in a high‑visibility project entering a critical phase.
- The chance to shape processes and systems that will support clinical manufacturing in the coming years.
- A collaborative environment with strong technical teams and modern aseptic facilities.
- Long‑term, on‑site engagement in the Twente region.
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