For an industrial production environment within a GMP-regulated sector, an experienced Validation Engineer is sought with expertise in the qualification of equipment, facilities, and utilities. You will be responsible for independently preparing, executing, and following up on qualification activities, ensuring that installations and systems comply with applicable quality standards and remain in a qualified state throughout their entire lifecycle.
What you do
- Prepare and execute qualification activities (DQ, IQ, OQ, PQ) for production installations, facilities, and utilities.
- Draft and review URS, risk analyses, test protocols, and qualification reports.
- Support commissioning & qualification (C&Q), including design reviews, FAT, SAT, and handover.
- Qualify production equipment, HVAC systems, purified water, compressed air, and temperature-controlled rooms.
- Manage and follow up on deviations, change controls, CAPAs, periodic reviews, and re-qualifications.
- Ensure correct GMP/GDP documentation, traceability, and data integrity.
- Coordinate with Engineering, Quality, Production, Maintenance, and external suppliers.
- Monitor the progress, quality, and compliance of assigned qualification activities.
What they ask
- Bachelor's or Master's degree in a technical or scientific field, or equivalent by experience.
- At least 2 years of relevant experience in validation, equipment qualification, or facility & utility qualification in a GMP environment.
- Good knowledge of GMP, GDP, EU GMP Annex 15, and the principles of qualification & validation.
- Experience with DQ/IQ/OQ/PQ, FAT/SAT, risk analyses, deviations, and change control.
- Familiar with drafting and executing qualification protocols and technical documentation.
Profile
- Independent, analytical, and structured, with a pragmatic approach.
- Strong communication skills.
- Fluent in Dutch and English.
Practical
- Collaboration with a long-term perspective.
- Challenging technical assignment within a GMP-regulated production environment.
- Responsibility and autonomy over individual qualification trajectories.
- Close collaboration with multidisciplinary engineering and quality teams.
How to apply
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