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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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.