Manufacturing (Validation) Engineer
Role Overview
We are looking for an experienced Manufacturing (Validation) Engineer to support equipment implementation and validation activities within a regulated medical device manufacturing environment in Groningen.
In this role, you will work closely with engineering, quality, operations, and suppliers to ensure manufacturing equipment and systems are properly designed, validated, and ready for production use. You will take ownership of validation documentation and execution, ensuring compliance with GMP/GxP/CSV requirements and supporting smooth industrialization of new equipment.
This is a hands-on role with a strong focus on validation delivery, technical documentation, and cross-functional coordination.
Key Responsibilities
- Lead and execute validation activities for manufacturing equipment and systems
- Create and manage validation documentation (URS, FAT, IQ, OQ, PQ, validation protocols and reports)
- Perform technical writing of validation plans and test protocols in collaboration with SMEs
- Execute validation testing and document results in a compliant and structured way
- Manage change control processes related to equipment and system validation
- Ensure compliance with GMP, GxP, and CSV requirements
- Collaborate with R&D, QA, Operations, and external suppliers
- Support industrialization and transfer of validated equipment into production
- Ensure validation deliverables are complete, traceable, and audit-ready
- Support training and documentation handover to operations teams
Requirements
Must Have
- Bachelor’s degree in Mechanical, Electrical, Industrial Engineering or related field
- Minimum 5 years of experience in Manufacturing or Industrial Engineering roles
- Strong experience in validation within MedTech, Pharma, or other cGMP-regulated industries
- Solid knowledge of GMP, GxP, and CSV fundamentals
- Experience with validation lifecycle (URS, FAT, IQ/OQ/PQ, reporting, closure)
- Experience working in change control environments
- Strong technical writing and documentation skills
- Ability to work cross-functionally with engineering, QA, and operations
- Fluent English (spoken and written, minimum B2 level)
Nice to Have
- MSc or PhD in relevant engineering discipline
- Experience with metrology or vision systems
- SCADA validation experience
- Six Sigma Green Belt or Black Belt certification
- Knowledge of high-precision machining or injection molding
- Dutch language skills
Additional Information
- Contract: 1 year
- Location: Groningen, Netherlands (fully on-site)
- Hours: 40 hours per week
- Language: English