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CQV Validation Engineer – Pharmaceutical Manufacturing
Job in
4800, Breda, North Brabant, Netherlands
Listed on 2026-07-01
Listing for:
SIRE LIFE SCIENCES
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Company
We are looking for candidates for a site engineering team supporting pharmaceutical technical projects within a regulated GMP environment.
Job DescriptionThis role is for a CQV Commissioning Qualification Validation Engineer (GMP). The engineer will support technical projects with minimal supervision and report to the Senior Manager Validation & Compliance. You will take a hands‑on approach to commissioning and qualification activities, develop and execute test strategies, and drive the creation of system commissioning qualification and validation documentation.
Responsibilities- Develop and update validation documentation, including system‑level criticality assessments, validation and commissioning/qualification plans, risk assessments, test protocols, and requirement traceability matrices
- Prepare and maintain commissioning, qualification, and validation summary reports
- Lead commissioning, qualification, and validation activities for technical solutions
- Provide technical guidance to project teams to ensure implemented solutions follow the validation plan and meet internal customer requirements
- Support delivery in line with established site procedures (SOPs)
- Carry out additional tasks or projects as requested by your supervisor
- At least 3 years of experience executing commissioning, qualification, and validation within pharmaceutical manufacturing
- Hands‑on commissioning and qualification experience in secondary packaging operations
- Experience with secondary packaging systems, including print and inspection systems (e.g., Systech, Cognex)
- Experience in Computerized Systems Validation
- Strong understanding of how single documents fit into the broader validation picture
- Ability to work within internal and/or external reporting relationships
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