GMP Validation Engineer

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

Company

Our client is a global leader in the pharmaceutical industry, operating in a highly regulated GMP environment. They run complex manufacturing and packaging operations and invest continuously in engineering projects that strengthen compliance, reliability, and quality across the site.

Job Description

Our client is looking for a GMP Validation Engineer to support engineering projects focused on secondary packaging equipment. The role will drive commissioning, qualification, and validation (CQV) activities and ensure solutions are implemented in line with site standards, documentation expectations, and GMP compliance.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for packaging-related systems.
• Develop, update, and maintain CQV documentation, such as: system criticality assessments, commissioning/qualification/validation plans, risk assessments, test protocols, requirements traceability matrices, CQV summary reports
• Define and report test strategies that meet internal customer requirements and standard CQV procedures.
• Provide technical guidance to project teams to ensure the implemented solution follows the validation approach and meets required standards.
• Coordinate priorities, identify risks, and elevate where needed to keep project phases on track (design, implementation, testing, commissioning, validation).
• Support additional tasks or engineering/validation projects as assigned by the supervisor.

Requirements

• Background in CQV (Commissioning, Qualification, Validation) within pharmaceutical manufacturing (at least 3 years hands-on experience).
• Experience with secondary packaging systems, ideally including print & inspection systems (e.g., Systech, Cognex).
• Experience with Computerized Systems Validation (CSV).
• Strong technical documentation skills and good English technical writing.
• Able to work independently with clear communication and strong stakeholder management.
• Comfortable working in a GMP environment with strong attention to quality and compliance.

Other Information

The role is based on-site in Breda, Netherlands, within an engineering organization focused on delivering compliant technical solutions in a structured project environment.