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Manufacturing Validation Engineer

Job in 9700, Groningen, Groningen, Netherlands
Listing for: SIRE LIFE SCIENCES
Full Time position
Listed on 2026-06-04
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer, Process Engineer, Pharma Engineer
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 60000 - 80000 EUR Yearly EUR 60000.00 80000.00 YEAR
Job Description & How to Apply Below
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 Med Tech, 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

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