{"schemaVersion":"jobsearcher.job.v1","id":"e53f985baaf41e297ffff6c5","url":"https://jobsearcher.com/jobs/e53f985baaf41e297ffff6c5","canonicalUrl":"https://jobsearcher.com/jobs/e53f985baaf41e297ffff6c5","title":"MV05-02126 Process Development Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nProcess Development Engineer\nRole Summary:\n\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\n\nKey Responsibilities:\n• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\n\nDesign and develop in-process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation; collaborate with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\n• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\n\nExperience Requirements:\n\n5-7+ years in manufacturing engineering or quality engineering within a regulated environment (medical devices, pharmaceuticals, diagnostics, biotechnology).\nStrong working knowledge of pertinent regulations like 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root cause investigation.\nExperience supporting new product introductions and process scale-up.\n\nQuality Expectations:\nDemonstrates commitment to patient safety and product quality by complying with all applicable quality procedures. Ensures proper documentation discipline and supports Quality System compliance.","company":"Validation","rawCompany":"validation","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:14:25.494Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"MV05-02126 Process Development Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nProcess Development Engineer\nRole Summary:\n\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\n\nKey Responsibilities:\n• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\n\nDesign and develop in-process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation; collaborate with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\n• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\n\nExperience Requirements:\n\n5-7+ years in manufacturing engineering or quality engineering within a regulated environment (medical devices, pharmaceuticals, diagnostics, biotechnology).\nStrong working knowledge of pertinent regulations like 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root cause investigation.\nExperience supporting new product introductions and process scale-up.\n\nQuality Expectations:\nDemonstrates commitment to patient safety and product quality by complying with all applicable quality procedures. Ensures proper documentation discipline and supports Quality System compliance.","datePosted":"2026-04-14T11:14:25.494Z","dateModified":"2026-04-14T11:14:25.494Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e53f985baaf41e297ffff6c5"},"url":"https://jobsearcher.com/jobs/e53f985baaf41e297ffff6c5"}}