Senior Equipment Validation Engineer

Seeking a Senior Equipment Validation Engineer to lead equipment and process validation activities in a regulated medical device manufacturing environment. This role will drive end-to-end validation lifecycle efforts, ensuring compliance with FDA, ISO, and cGMP requirements while supporting new equipment introductions, process improvements, and audit readiness.

• Lead equipment qualification activities (IQ/OQ/PQ/TMV) for manufacturing and test equipment.
• Develop and execute validation protocols, risk assessments (FMEA), traceability matrices, and summary reports.
• Support process validation, change control, and deviation management.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, cGMP, and GAMP guidelines.
• Provide validation oversight for NPI, equipment transfers, and re-qualification activities.
• Act as SME during internal and regulatory audits.
• Support Computer System Validation (CSV) and related validation initiatives.

• Bachelor’s degree in Engineering or related field.
• 7+ years of medical device validation experience.
• Strong hands‑on experience with IQ/OQ/PQ and validation documentation.
• Knowledge of FDA QSR, ISO 13485, and GxP regulations.
• Experience with eQMS systems (Track Wise, Master Control, or similar).

• CSV and automation validation experience.