{"schemaVersion":"jobsearcher.job.v1","id":"d8be9b081d52f37a892001b6","url":"https://jobsearcher.com/jobs/d8be9b081d52f37a892001b6","canonicalUrl":"https://jobsearcher.com/jobs/d8be9b081d52f37a892001b6","title":"Manufacturing Process Validation Engineer","description":"Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements, Good Manufacturing Practices (GMP).\n\nJob Responsibilities: Assist in coordinating and supporting suppliers for manufacturing of custom equipment/tooling.\nAssist in coordinating purchase and delivery of equipment/tooling.\nAssist in coordinating installation of equipment/tooling.\nSupport developing and executing IQ and OQ protocols and reports.\nSupport developing and executing test method validations / Gage R&R.\nSupport generating and issuing SOPs and manufacturing procedures for approval.\nSupport developing and executing component qualifications.\nSupport developing and executing PQ and PPQ protocols and reports.\nSupport developing manufacturing capacity analysis.\nSupport developing and executing process characterizations / Design of Experiments (DOE).\nSupport developing documentation/justification for capital projects.\nEnsure compliance with cGMPs, quality standards, policies, and procedures.\nPerform other duties as assigned by the Process Validation Lead and supervisors.\n\nQualifications:\nKnowledge and Skills: Bachelor's degree in engineering.\nExperience in the medical device industry, specifically in manufacturing process validation.\nExcellent written and verbal communication skills in English and Spanish.\nExperience with qualification/validation (IQ/OQ/PQ).\nExperience with test method validation and Gage R&R.\nKnowledge of process characterization and Design of Experiments (DOE).\nExperience in manufacturing line design and capacity analysis.\nDesign experience with equipment and tooling.\nExperience in equipment installation and preventive maintenance procedures.\nAbility to perform root cause analysis and investigations.\nExperience in SOP and manufacturing procedure generation and change control.\nUnderstanding of product financials and supply chain design.\nFamiliarity with OEE integration, vertical startup, and zero-loss mindset.\n\nRequired Education and Experience: Bachelor's degree in engineering or related field with at least 3 years of engineering experience, or a master's degree with at least 2 years of engineering experience.\n\n#J-18808-Ljbffr","company":"TechDigital Group","rawCompany":"techdigital group","city":"El Paso","state":"TX","isRemote":false,"isActive":true,"createdAt":"2026-06-20T05:06:59.644Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-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":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manufacturing Process Validation Engineer","description":"Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements, Good Manufacturing Practices (GMP).\n\nJob Responsibilities: Assist in coordinating and supporting suppliers for manufacturing of custom equipment/tooling.\nAssist in coordinating purchase and delivery of equipment/tooling.\nAssist in coordinating installation of equipment/tooling.\nSupport developing and executing IQ and OQ protocols and reports.\nSupport developing and executing test method validations / Gage R&R.\nSupport generating and issuing SOPs and manufacturing procedures for approval.\nSupport developing and executing component qualifications.\nSupport developing and executing PQ and PPQ protocols and reports.\nSupport developing manufacturing capacity analysis.\nSupport developing and executing process characterizations / Design of Experiments (DOE).\nSupport developing documentation/justification for capital projects.\nEnsure compliance with cGMPs, quality standards, policies, and procedures.\nPerform other duties as assigned by the Process Validation Lead and supervisors.\n\nQualifications:\nKnowledge and Skills: Bachelor's degree in engineering.\nExperience in the medical device industry, specifically in manufacturing process validation.\nExcellent written and verbal communication skills in English and Spanish.\nExperience with qualification/validation (IQ/OQ/PQ).\nExperience with test method validation and Gage R&R.\nKnowledge of process characterization and Design of Experiments (DOE).\nExperience in manufacturing line design and capacity analysis.\nDesign experience with equipment and tooling.\nExperience in equipment installation and preventive maintenance procedures.\nAbility to perform root cause analysis and investigations.\nExperience in SOP and manufacturing procedure generation and change control.\nUnderstanding of product financials and supply chain design.\nFamiliarity with OEE integration, vertical startup, and zero-loss mindset.\n\nRequired Education and Experience: Bachelor's degree in engineering or related field with at least 3 years of engineering experience, or a master's degree with at least 2 years of engineering experience.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T05:06:59.644Z","dateModified":"2026-06-20T05:06:59.644Z","hiringOrganization":{"@type":"Organization","name":"TechDigital Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"El Paso","addressRegion":"TX","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"d8be9b081d52f37a892001b6"},"url":"https://jobsearcher.com/jobs/d8be9b081d52f37a892001b6"}}