Manufacturing Engineer Validation, Groningen, Groningen

The Company
A global organization in the medical technology and pharmaceutical sector, focused on developing innovative solutions that improve patient outcomes. The company operates in a highly regulated environment with a strong emphasis on quality, compliance, and advanced manufacturing technologies.

Role Description
This role focuses on the implementation and validation of manufacturing equipment within a high precision production environment. You will collaborate closely with engineering and cross functional teams to ensure new technologies meet quality and business requirements. The position plays a key role in scaling validated processes globally and supporting smooth handovers to operational teams.

Responsibilities
- Write technical validation protocols and execute validation activities in collaboration with subject matter experts.
- Gather requirements and create documentation such as URS, technical manuals, FAT, IQ, OQ, and PQ.
- Act as a subject matter expert for GXP, GMP, and CSV related to hardware equipment solutions.
- Lead validation lifecycle activities from change request creation through final closure.
- Communicate and collaborate with R and D, quality, operations, and external suppliers.
- Implement equipment validation strategies that enable global scalability.
- Design and execute test plans and validation documentation.
- Deliver validation reports and ensure completion of all validation activities.
- Support handover by providing documentation and training to relevant departments.

Requirements
- Bachelor degree in Mechanical, Electrical, or Engineering related field.
- Minimum 5 years experience in manufacturing or industrial engineering in high volume environments.
- Strong knowledge of GMP, GXP, and CSV principles.
- Proven experience as a validation expert in regulated industries such as medical devices or pharmaceuticals.
- Experience with change control processes and validation lifecycle management.
- Excellent English communication skills at B2 level or higher.
- Strong teamwork and hands on mindset.
- Experience with metrology or vision systems is an advantage.
- Knowledge of SCADA systems is preferred.
- Six Sigma certification is a plus.
- Experience with high precision machining or injection molding is beneficial.
- Dutch is plus.

Other Information
- Collaboration with global teams and suppliers.
- Opportunity to work in a highly regulated and innovative manufacturing environment.

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