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.

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.