Equipment Engineer

Overview

We are seeking a Senior Validation Engineer to lead equipment and process validation activities in a regulated medical device manufacturing environment. This role is responsible for managing validation lifecycle activities, ensuring regulatory compliance, and independently driving validation projects from protocol development through execution and final reporting.

• Lead equipment qualification activities (IQ, OQ, TMV, PQ) for manufacturing and test equipment.
• Oversee process validation to ensure compliance with FDA and ISO requirements.
• Author and review validation documentation including protocols, validation plans, FMEA, traceability matrices, deviations, and summary reports.
• Support new equipment introductions, transfers, re-qualifications, and change control activities.
• Ensure compliance with FDA 21 CFR Part 820, Part 11, ISO 13485, ISO 9001, cGMP, Annex 11, and GAMP.
• Partner cross-functionally with Manufacturing, Quality, Engineering, R&D, and Regulatory teams.
• Support audits as a validation SME.
• Assist with Computer System Validation (CSV) and software validation as needed.

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