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1. Job Title
CQV Engineer (GMP)
2. Sector
Pharmaceutical / Medical Device Manufacturing
3. Role
The CQV Engineer is responsible for commissioning, qualification, and validation activities within a GMP manufacturing environment. The role focuses on hands-on execution and documentation for secondary packaging systems, ensuring systems meet regulatory and internal requirements. The position reports to Validation & Compliance within Site Engineering.
4. Non-Negotiable Requirements
- Degree in Engineering or related technical discipline
- Minimum 3 years of CQV experience in a pharmaceutical or medical device manufacturing environment
- Hands-on commissioning and qualification experience in secondary packaging operations
- Experience with secondary packaging equipment using print and inspection systems
- Computerized Systems Validation (CSV) experience
- Experience creating GMP-compliant CQV documentation
5. Essential Requirements
- Experience developing validation and commissioning plans
- Experience performing risk assessments and criticality assessments
- Experience executing IQ, OQ, and PQ activities
- Experience writing test protocols and validation reports
- Experience creating requirement traceability matrices
- Experience supporting engineering projects in a GMP environment
6. Desirable Requirements
- Experience with Systech systems
- Experience with Cognex vision systems
- Experience working independently or with remote teams
- Experience supporting multiple project phases from design through validation
Practical Information
Location: Breda, The Netherlands
Start Date: ASAP
Work Model: Full time
Interested or know someone who might be?
Send your CV or inquiries to [email protected]
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