Required Skills & Experience
-5+ years of Quality Engineering / Validation Engineering experience, preferably within medical device, pharmaceutical, or another regulated manufacturing environment -Strong hands-on experience with equipment validation and qualification -Strong experience developing and executing IQ/OQ/PQ protocols -Experience with process validation -Experience with Gauge R&R / measurement system analysis -Experience creating, executing, and closing out validation protocols and supporting documentation -Ability to independently own validation activities from planning through execution and closeout -Experience working with a variety of manufacturing and production equipment -Strong troubleshooting and problem-solving capabilities -Ability to work cross-functionally with Quality, Manufacturing, and Engineering teams -Highly self-sufficient and able to manage deliverables with limited oversight -Ability to work onsite in the Danvers, MA area to support equipment transfers and validation activities
Nice to Have Skills & Experience
-Medical device manufacturing experience -Previous experience within J&J / Abiomed or a similarly regulated medical device environment -Experience supporting equipment relocation, manufacturing transfers, site transfers, or production line transfers -Experience supporting Business Continuity Planning (BCP) initiatives -Experience validating a broad range of equipment, including manufacturing machinery, gauges, laser equipment, benches/workstations, and other production assets -Experience working in an environment operating under heightened Quality/FDA remediation or inspection-readiness activities
Job Description
Insight Global is seeking an experienced Quality Validation Engineer to support a large-scale equipment transfer and Business Continuity Planning (BCP) initiative within a medical device manufacturing environment in Danvers, MA. This individual will be responsible for owning validation activities associated with moving manufacturing equipment between production areas and sites, including bringing transferred equipment back into a qualified and operational state.
The Validation Engineer will lead validation activities from planning through execution and closeout, including IQ/OQ/PQ, process validation, equipment qualification, Gauge R&R, and associated documentation. The equipment being transferred will vary significantly and may include manufacturing machinery, benches/workstations, gauges, laser equipment, and other production assets.
This person will work cross-functionally with engineering, manufacturing, quality, and other project stakeholders to coordinate validation activities around equipment moves and project timelines. The ideal candidate will be experienced, hands-on, and highly self-sufficient, with the ability to independently drive validation work forward and escalate issues when necessary without requiring significant day-to-day oversight.