The Company
Our client is a global leader in medical device manufacturing, operating in a highly regulated cGMP environment and focused on delivering innovative healthcare solutions worldwide.

Role Overview
As a Manufacturing Engineer within Asset Management, you will lead equipment implementation and validation activities, ensuring new and modified equipment meets design, quality, and business requirements while enabling global scalability.

Key Responsibilities
- Lead equipment validation activities (URS, FAT, IQ/OQ/PQ, CSV)
- Act as validation SME within a regulated medical device environment
- Own change controls from initiation to closure
- Collaborate with R&D, QA, Operations, and external suppliers
- Develop and execute validation plans, protocols, and reports
- Support global equipment rollouts and knowledge transfer
- Perform risk analysis, root cause investigations, and process improvements
- Write SOPs, protocols, and provide training to stakeholders

Requirements
- Bachelor’s degree in Engineering or related field
- 5+ years in Manufacturing / Industrial Engineering
- Strong experience with equipment validation (IQ/OQ/PQ)
- GMP, GxP, CSV knowledge
- Experience in medical device, pharma, or cGMP manufacturing
- Proficiency in English (B2+)
- MSc or PhD
- Dutch language skills
- SCADA / vision systems experience
- Six Sigma Green or Black Belt
- Metrology or high-precision manufacturing experience

Apply Now
Interested in shaping high-quality medical manufacturing processes? Apply today and take the next step in your engineering career.

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