{"schemaVersion":"jobsearcher.job.v1","id":"9e6d9cee7b14f6345a02932c","url":"https://jobsearcher.com/jobs/9e6d9cee7b14f6345a02932c","canonicalUrl":"https://jobsearcher.com/jobs/9e6d9cee7b14f6345a02932c","title":"Process Validation Engineer","description":"We are seeking Process / Equipment Validation Engineers to support the installation, commissioning, qualification, and validation of 50+ silicone injection molding machines within a regulated manufacturing environment.\nThis is a hands-on, fast-paced role within a small organization where engineers are expected to take ownership of validation workstreams, proactively identify gaps, and drive execution with minimal oversight.\nKey Responsibilities Support equipment installation, commissioning, and qualification (IQ/OQ/PQ) for silicone injection molding machinery\nAssist with new tooling installation and tooling replacement/changeovers\nAuthor, execute, and review validation documentation, including:\nURS\nRisk Assessments (FMEA or equivalent)\nIQ / OQ / PQ protocols and reports\nTraceability matrices\nLead hands-on protocol execution, testing, and data analysis\nSupport process validation activities following equipment qualification\nCollaborate with Engineering, Manufacturing, Quality, and external vendors\nEnsure compliance with GMP, ISO 13485, and internal quality system requirements\nMaintain inspection-ready documentation and support audit readiness\nRequired Qualifications 5+ years of experience as a Process or Equipment Validation Engineer\nHands-on experience executing IQ/OQ/PQ for manufacturing equipment\nStrong understanding of equipment qualification and validation lifecycle\nExperience working in ISO 13485 and/or GMP-regulated environments\nProven ability to independently manage validation activities in a fast-paced setting\nPreferred Qualifications Experience with injection molding equipment (silicone injection molding strongly preferred)\nExperience supporting tooling installation or tooling changeovers\nPPAP (Production Part Approval Process) experience\nBackground in medical device or pharmaceutical manufacturing\nExperience working in a small or mid-sized manufacturing organization\n\n#J-18808-Ljbffr","company":"United Pharma Technologies","rawCompany":"united pharma technologies","city":"Sturtevant","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-07-16T04:09:00.364Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Validation Engineer","description":"We are seeking Process / Equipment Validation Engineers to support the installation, commissioning, qualification, and validation of 50+ silicone injection molding machines within a regulated manufacturing environment.\nThis is a hands-on, fast-paced role within a small organization where engineers are expected to take ownership of validation workstreams, proactively identify gaps, and drive execution with minimal oversight.\nKey Responsibilities Support equipment installation, commissioning, and qualification (IQ/OQ/PQ) for silicone injection molding machinery\nAssist with new tooling installation and tooling replacement/changeovers\nAuthor, execute, and review validation documentation, including:\nURS\nRisk Assessments (FMEA or equivalent)\nIQ / OQ / PQ protocols and reports\nTraceability matrices\nLead hands-on protocol execution, testing, and data analysis\nSupport process validation activities following equipment qualification\nCollaborate with Engineering, Manufacturing, Quality, and external vendors\nEnsure compliance with GMP, ISO 13485, and internal quality system requirements\nMaintain inspection-ready documentation and support audit readiness\nRequired Qualifications 5+ years of experience as a Process or Equipment Validation Engineer\nHands-on experience executing IQ/OQ/PQ for manufacturing equipment\nStrong understanding of equipment qualification and validation lifecycle\nExperience working in ISO 13485 and/or GMP-regulated environments\nProven ability to independently manage validation activities in a fast-paced setting\nPreferred Qualifications Experience with injection molding equipment (silicone injection molding strongly preferred)\nExperience supporting tooling installation or tooling changeovers\nPPAP (Production Part Approval Process) experience\nBackground in medical device or pharmaceutical manufacturing\nExperience working in a small or mid-sized manufacturing organization\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T04:09:00.364Z","dateModified":"2026-07-16T04:09:00.364Z","hiringOrganization":{"@type":"Organization","name":"United Pharma Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sturtevant","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9e6d9cee7b14f6345a02932c"},"url":"https://jobsearcher.com/jobs/9e6d9cee7b14f6345a02932c"}}