Company:
A global medical technology organization operating in a highly regulated manufacturing environment. The site focuses on advanced surgical and vision related products with strong emphasis on quality, validation, and scalable production technologies.
Job Description:
This role focuses on implementing and validating manufacturing equipment in a regulated medical device environment. You will act as the technical expert for equipment validation, ensuring compliance, quality, and readiness for global scaling. Close collaboration with engineering, quality, operations, and suppliers is central to success in this position.
Responsibilities:
- Lead equipment implementation and validation activities in collaboration with engineering teams
- Write and execute validation documentation including URS, TM, FAT, IQ, OQ, and PQ
- Act as subject matter expert for GMP, GXP, and CSV related to hardware equipment
- Manage change control activities from CR creation through VSR and closure
- Develop and execute validation test protocols and write validation reports
- Coordinate with R and D, Quality Assurance, Operations, and external suppliers
- Support handover to production through documentation and training
- Ensure equipment validation supports global scalability across production sites
- Design and deliver test plans and validation strategies aligned with business targets
Requirements:
- Bachelor of Science in Mechanical, Electrical, or Engineering related discipline
- Minimum 5 years’ experience in manufacturing or industrial engineering within medium to high volume production
- Proven experience as validation SME in MedTech, pharma, or cGMP regulated environments
- Strong knowledge of GMP, GXP, and CSV fundamentals
- Experience leading equipment validation and change control activities
- Hands on mindset with strong collaboration skills
- English proficiency at minimum B2 level
- Dutch is Plus
Other Information:
- On site manufacturing environment
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58123
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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.