Manufacturing Engineer Validation

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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