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. Responsibilities 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. Required Qualifications 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 (TrackWise, MasterControl, or similar). Strong technical writing and communication skills. #J-18808-Ljbffr