Senior Validation Engineer (Equipment & Manufacturing)
We are supporting a leading medical device manufacturer seeking an experienced Validation Engineer to support equipment qualification and manufacturing validation activities across a regulated production environment.
This role will play a key part in delivering validation projects for new and existing manufacturing equipment, ensuring compliance with applicable quality and regulatory requirements while supporting operational excellence across the site.
Location: Ile-de-France, France (hybrid)
Start Date: Mid September - October
Key Responsibilities
- Lead qualification and validation activities for manufacturing equipment, production machinery and associated systems.
- Develop and execute validation documentation including Validation Plans, IQ, OQ, PQ protocols and final reports.
- Perform risk assessments to define validation strategies and testing requirements.
- Support the introduction of new manufacturing equipment and process improvements.
- Coordinate validation activities with engineering, quality, production and external suppliers.
- Review and approve qualification documentation generated by vendors and third parties.
- Investigate validation deviations, implement corrective actions and ensure timely resolution.
- Ensure validation activities comply with ISO 13485, EU MDR and applicable regulatory expectations.
- Provide validation expertise during audits and regulatory inspections.
- Track project progress and communicate updates to key stakeholders.
Candidate Profile
- 5+ years' experience in equipment qualification, process validation or manufacturing validation within a regulated industry.
- Proven experience executing IQ, OQ and PQ activities for manufacturing equipment and production machinery.
- Strong understanding of validation lifecycle methodologies, risk assessments and deviation management.
- Familiarity with ISO 13485, GMP/GxP and regulated manufacturing environments.
- Fluent English with the ability to work independently and collaborate with cross-functional teams.
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