Engineer

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]