Qualification Engineer - Sterile Fill‑Finish On‑Site Utrecht
This short‑term contract position requires a Dutch‑speaking Qualification Engineer who can work fully on‑site in Utrecht/Bilthoven to support the qualification of a sterile fill‑finish production line. The role focuses on delivering compliant, inspection‑ready qualification of equipment, cleanrooms, utilities, and monitoring systems in accordance with GMP, EU Annex 1, and ISO 14644/14698. The engineer collaborates closely with QA, Engineering, Operations, and vendors to ensure the fill‑finish line is qualified on time and ready for aseptic manufacturing.
Key Responsibilities
- Execute and document qualification activities (IQ/OQ/PQ) for sterile fill‑finish equipment, including filling machines, isolators/BSCs, sterilisation systems, VHP units, and packaging components.
- Qualify cleanrooms (Grade B/C/D) and controlled environments, including classification, airflow, pressure cascade, and contamination‑control verification.
- Lead qualification of clean utilities such as PW, WFI, clean steam, clean gases, HVAC, and temperature‑controlled storage supporting aseptic operations.
- Support process validation activities including media fills, aseptic process simulations, and cleaning validation.
- Review and approve protocols, reports, deviations, CAPAs, and change controls related to fill‑finish operations.
- Participate in FAT/SAT, commissioning, troubleshooting, and readiness for routine manufacturing.
- Ensure compliance with EU GMP Annex 1, ISO 14644/14698, GAMP5, and site validation standards.
- Prepare documentation for internal audits, customer audits, and regulatory inspections.
Required Experience
- Proven experience qualifying aseptic or sterile fill‑finish equipment and processes.
- Strong background in cleanroom qualification, contamination control, and environmental monitoring.
- Hands‑on experience with clean utilities qualification (PW, clean steam, clean gases, HVAC).
- Solid understanding of GMP, Annex 1, data integrity, and validation lifecycle principles.
- Experience in biologics, vaccines, or high‑containment (BSL‑2/BSL‑3) environments is advantageous.
- Ability to coordinate cross‑functional teams and manage vendor interactions.
Additional Requirements
- Fluent Dutch (spoken and written).
- Full on‑site presence in Utrecht/Bilthoven for the duration of the contract.
- Availability for a short‑term assignment with immediate impact on project timelines.
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