Validation Engineer - Medical Devices

About the role

Validation Engineer responsible for supporting qualification and validation of manufacturing lines to ensure compliance with medical device standards and operational readiness.

Responsibilities

• Develop, update, and execute qualification protocols including Installation, Operational, and Performance Qualification (IOPQ).
• Collaborate with SMEs and cross-site teams to gather requirements, translate them into test cases, and ensure consistent execution.
• Navigate complex Quality Management Systems (QMS) to ensure documentation compliance.
• Support IOPQ activities through international travel, participate in dry runs and live tests, generate qualification reports, and maintain clear communication with stakeholders.
• Provide regular status updates, flag risks, and produce final documentation.

Requirements

• Mid-senior level experience in validation within medical device manufacturing.
• Strong collaboration and communication skills.
• Proficiency in protocol development and quality systems.
• Ability to work across global teams.
• Ability to travel internationally is expected.