GMP CQV Engineer: Packaging Systems Specialist

Sire Search; Breda; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sire Search in Breda, Netherlands is seeking a GMP Validation Engineer to lead CQV activities for packaging-related systems. You will drive commissioning, qualification, and validation, ensuring alignment with site standards and GMP compliance.

You will develop CQV documentation, assess risks, and report test strategies while guiding project teams to deliver validated and compliant solutions.

Qualifications

• At least 3 years hands-on CQV experience in pharmaceutical manufacturing.
• Experience with secondary packaging systems, including print & inspection.
• Experience with Computerized Systems Validation (CSV).
• Strong technical documentation and English technical writing skills.
• Ability to work independently with clear communication and stakeholder management.
• GMP environment experience and focus on quality and compliance.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for packaging-related systems.
• Develop, update, and maintain CQV documentation (e.g., plans, risk assessments, test protocols, CQuV reports).
• Define and report test strategies meeting internal requirements and CQV procedures.
• Provide technical guidance to project teams to ensure quality validation.
• Coordinate priorities, identify risks, and escalate to keep phases on track.
• Support additional tasks or validation projects as assigned by supervisor.

Skills

CQV experience

Technical documentation

English technical writing

Stakeholder management

Tools

Systech

Cognex

Job description

Sire Search in Breda, Netherlands is seeking a GMP Validation Engineer to lead CQV activities for packaging-related systems. You will drive commissioning, qualification, and validation, ensuring alignment with site standards and GMP compliance.

You will develop CQV documentation, assess risks, and report test strategies while guiding project teams to deliver validated and compliant solutions.