CQV Engineer

The Company

The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials.

We are seeking a CQV Engineer to join the site Engineering team under GMP standards. Reporting to the Senior Manager of Validation & Compliance, this role involves supporting technical projects with minimal supervision. The CQV Engineer will be responsible for developing and executing commissioning, qualification, and validation strategies, ensuring compliance with internal requirements and standard procedures. This is a hands‑on position focused on packaging systems and validation documentation.

• Preparing and updating validation documents such as System‑level criticality assessments, commissioning, qualification, and validation plans, risk assessments, test protocols, requirement traceability matrices, and summary reports for CQV activities.
• Leading commissioning, qualification, and validation of activities for technical systems.
• Providing guidance to project teams to ensure technical solutions align with validation plans and internal SOPs.
• Supporting additional tasks or projects as assigned by the supervisor.

• Degree in Engineering or related field.
• Minimum 3 years of experience in CQV within pharmaceutical manufacturing.
• Hands‑on experience with secondary packaging systems, including print and inspection technologies (e.g., Systech, Cognex).
• Proficiency in computerized systems validation.
• Strong understanding of GMP compliance and validation documentation.

Apply to our vacancy form for more information. Looking forward to getting in touch!

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