Find & Apply For Validation Engineer Jobs in Bethlehem, Connecticut

We're looking for a Process Engineer to own and improve our injection molding and secondary manufacturing processes in a regulated medical device environment. You'll make sure our processes are reliable, compliant, and produce consistent quality — and you'll be the go-to technical expert for the production floor. What you'll do Own the manufacturing processes for your assigned lines — set the critical parameters, keep them in control, and troubleshoot when things drift. Use SPC and capability data (Cp/Cpk) to catch problems early and drive them out. Run process validations (IQ/OQ/PQ) and keep documentation current — process flows, pFMEAs, control plans, work instructions, validation reports. Work with Quality on nonconformances, deviations, CAPAs, and complaints, and represent manufacturing in audits. Support new product launches — join design reviews, flag manufacturability issues early, and build out the validation plan. Lead continuous improvement work (scrap, yield, cycle time, downtime) using Lean/Six Sigma tools like DMAIC and 8D. Train operators and techs, and mentor junior engineers. Requirements Bachelor's in Mechanical, Plastics, Manufacturing, or Industrial Engineering (or similar). 3-7 years in manufacturing/process engineering. Injection molding experience in a regulated environment — medical device experience is a strong plus. Solid grounding in SPC, process validation, pFMEAs, control plans, and root-cause problem solving. Familiarity with ISO 13485 and FDA QSR preferred; scientific molding knowledge a plus. Comfortable spending real time on the shop floor, juggling multiple priorities. To be considered, please apply with a resume. If you have any other questions you can reach out to Shane Burch at (904) 420-6296 or shane.burch@gogpac.com