Process Engineer, Groningen, Groningen

About the company
Our client is a leading global organisation within the medical device industry, committed to innovation and excellence in surgical vision solutions. They operate in a highly regulated environment and focus on delivering cutting-edge technologies that improve patient outcomes worldwide.

Role description
We are seeking an experienced Process Engineer to join the Asset Management team. In this role, you will lead equipment implementation activities, collaborate with engineering teams on technology and equipment development, and ensure compliance with validation standards. You will act as a subject matter expert in GXP, GMP, and CSV, supporting seamless integration of new equipment into production lines.

Key responsibilities

• Develop and execute validation protocols in collaboration with SMEs.
• Gather requirements and write technical documentation (URS, TM, FAT, IQ, OQ, PQ) for machines and equipment, including software components.
• Lead change control processes and validation activities from CR creation to VSR and CR closure.
• Communicate and collaborate with R&D, QA, Operations, and external suppliers.
• Implement scalable equipment validation processes across global operations.
• Design and execute test plans, analyse results, and report findings.
• Perform risk and root cause analysis for products and processes.
• Develop and improve product and process designs, test methods, and SOPs.
• Organise engineering and verification studies, including protocol setup and execution.
• Train employees and ensure proper documentation for handover to other departments.

• Bachelor’s degree in Mechanical, Electrical, or related Engineering discipline.
• Minimum 5 years’ experience in Manufacturing or Industrial Engineering within medium/high-volume production.
• Strong knowledge of Design for Manufacturing principles (Lean, Tolerancing, Poka Yoke, Theory of Constraints).
• Proficient in statistical analysis using Minitab.
• Expertise in GMP, GXP, and CSV fundamentals.
• Proven track record as validation SME in medtech, pharma, or other regulated sectors.
• Excellent English communication skills (B2 level or higher).

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