GMP Validation Engineer, Breda, Noord-Brabant

The Company
A global pharmaceutical manufacturing organization operating in a highly regulated GMP environment. The company focuses on quality driven engineering, compliance, and reliable delivery of life saving medicines.

Role Description
The GMP Validation Engineer supports engineering and technical projects within a manufacturing site. The role focuses on commissioning, qualification, and validation activities to ensure systems meet regulatory and internal quality requirements. This position works closely with engineering, project, and compliance teams.

Responsibilities
- Develop, review, and update validation documentation
- Prepare system level criticality assessments
- Create commissioning, qualification, and validation plans
- Perform risk assessments and develop test protocols
- Build and maintain requirement traceability matrices
- Execute and lead commissioning, qualification, and validation testing
- Prepare commissioning, qualification, and validation summary reports
- Provide technical guidance to project teams to ensure alignment with validation plans and SOPs
- Support projects to meet internal customer and compliance requirements
- Perform additional tasks or projects assigned by the supervisor

Requirements
- Minimum 3 years experience in commissioning, qualification, and validation within pharmaceutical manufacturing
- Hands on experience with secondary packaging systems
- Experience with print and inspection systems such as serialization and vision inspection platforms
- Strong experience in computerized systems validation
- Solid understanding of GMP regulations and practices
- Ability to understand how individual validation documents fit into the overall lifecycle
- Experience working with internal and external stakeholders
- Strong English technical writing skills
- Good communication and reporting skills

Other Information
Involvement across design, implementation, testing, commissioning, and validation phases

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