CQV Engineer
Location: Netherlands (On-site)
Summary: We are seeking a skilled CQV Engineer to join our team in the Netherlands. The ideal candidate will be responsible for Commissioning, Qualification, and Validation (CQV) activities, including but not limited to Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
Key Responsibilities:
- Prepare validation documents including URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Execute IQ/OQ and PQ for equipment, systems, and utilities.
- Write reports of completed CQV activities.
- Stay informed of industry regulatory changes as they apply to equipment/facility validation.
- Support in writing and/or revising procedures applicable to Engineering activities.
- Assist the Engineering group in preparing the validation, re-qualification, and maintenance program.
- Supporting the Cell and Gene Units
Key Requirements:
- Bachelor's degree or equivalent in a relevant subject area.
- Flexibility and adaptability to perform in an ever-changing environment.
- Demonstrable (3-6 years) experience within a validation role.
- Experience in GMP environment or similar, familiar with GDocP, Data Integrity, and ALCOA++.
- Strong planning skills and self-motivated, able to work autonomously.
- Business-level fluency in English; other languages are nice to have but not required.
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