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.