{"schemaVersion":"jobsearcher.job.v1","id":"9c9ef1b3d4e71ce177cf51ad","url":"https://jobsearcher.com/jobs/9c9ef1b3d4e71ce177cf51ad","canonicalUrl":"https://jobsearcher.com/jobs/9c9ef1b3d4e71ce177cf51ad","title":"Validation Engineer","description":"We are seeking an experienced Validation Engineer with strong Change Management / Change Control experience to support controlled-temperature equipment and GMP validation activities within a pharmaceutical or biotechnology manufacturing environment.\n\nThe ideal candidate will have hands-on experience supporting CTU/CTE activities, stability chambers, freezers, refrigerators, and other temperature-controlled equipment, along with strong knowledge of GMP change control processes, qualification documentation, risk assessments, deviations, and lifecycle management.\n\nThis individual will work closely with Quality, Validation, Engineering, Manufacturing, Facilities, and Laboratory teams to ensure equipment changes are appropriately assessed, documented, qualified, and maintained in a validated state.\n\nKey Responsibilities\n\nManage and support Change Control / Change Management activities associated with GMP equipment, laboratory systems, utilities, and controlled-temperature units.\n\nInitiate, assess, execute, and close change controls in accordance with site Quality Management System requirements.\n\nSupport CTU and CTE qualification and validation activities.\n\nStability chambers\n\nWalk-in chambers\n\nCold rooms\n\nIncubators\n\nOther controlled-temperature storage systems\n\nDevelop, review, and execute qualification protocols including IQ, OQ, PQ and requalification activities.\n\nSupport temperature mapping studies and evaluate temperature distribution, hot/cold spots, alarm settings, and acceptance criteria.\n\nDevelop and review validation protocols, reports, risk assessments, traceability documentation, and supporting technical documentation.\n\nAssess equipment modifications and determine the appropriate validation or requalification impact.\n\nPerform change impact assessments related to equipment, facilities, utilities, processes, and computerized or monitoring systems.\n\nCoordinate change implementation activities with Engineering, Facilities, Quality, Validation, Manufacturing, and laboratory personnel.\n\nEnsure all required validation deliverables are completed prior to Change Control closure.\n\nSupport deviations, investigations, CAPAs, and corrective actions associated with qualification or temperature-controlled equipment.\n\nReview discrepancies encountered during protocol execution and assist with root-cause investigations.\n\nSupport calibration, preventive maintenance, alarm verification, and equipment lifecycle activities where applicable.\n\nEnsure equipment remains in a validated and compliant state following modifications, repairs, upgrades, or relocation.\n\nSupport periodic review and requalification programs for GMP equipment.\n\nMaintain accurate documentation in accordance with cGMP, GDP, data integrity, and site procedures.\n\nParticipate in inspection-readiness activities and support internal, client, and regulatory audits.\n\nRequired Qualifications\n\nBachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.\n\nApproximately 5+ years of validation, qualification, engineering, or quality experience within pharmaceutical, biotechnology, or another GMP-regulated environment.\n\nStrong hands‑on experience with Change Control / Change Management.\n\nHands‑on experience with stability chambers, freezers, refrigerators, cold rooms, or similar temperature‑controlled equipment.\n\nExperience developing and executing IQ/OQ/PQ protocols and qualification reports.\n\nUnderstanding of temperature mapping and controlled‑temperature equipment qualification.\n\nExperience performing validation impact assessments and risk assessments.\n\nFamiliarity with deviations, CAPAs, investigations, and GMP documentation.\n\nStrong knowledge of cGMP requirements and Good Documentation Practices.\n\nAbility to independently manage validation/change‑control deliverables and coordinate across multiple functional teams.\n\n#J-18808-Ljbffr","company":"United Pharma Technologies","rawCompany":"united pharma technologies","city":"Millbrae","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-25T03:47:41.908Z","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":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"We are seeking an experienced Validation Engineer with strong Change Management / Change Control experience to support controlled-temperature equipment and GMP validation activities within a pharmaceutical or biotechnology manufacturing environment.\n\nThe ideal candidate will have hands-on experience supporting CTU/CTE activities, stability chambers, freezers, refrigerators, and other temperature-controlled equipment, along with strong knowledge of GMP change control processes, qualification documentation, risk assessments, deviations, and lifecycle management.\n\nThis individual will work closely with Quality, Validation, Engineering, Manufacturing, Facilities, and Laboratory teams to ensure equipment changes are appropriately assessed, documented, qualified, and maintained in a validated state.\n\nKey Responsibilities\n\nManage and support Change Control / Change Management activities associated with GMP equipment, laboratory systems, utilities, and controlled-temperature units.\n\nInitiate, assess, execute, and close change controls in accordance with site Quality Management System requirements.\n\nSupport CTU and CTE qualification and validation activities.\n\nStability chambers\n\nWalk-in chambers\n\nCold rooms\n\nIncubators\n\nOther controlled-temperature storage systems\n\nDevelop, review, and execute qualification protocols including IQ, OQ, PQ and requalification activities.\n\nSupport temperature mapping studies and evaluate temperature distribution, hot/cold spots, alarm settings, and acceptance criteria.\n\nDevelop and review validation protocols, reports, risk assessments, traceability documentation, and supporting technical documentation.\n\nAssess equipment modifications and determine the appropriate validation or requalification impact.\n\nPerform change impact assessments related to equipment, facilities, utilities, processes, and computerized or monitoring systems.\n\nCoordinate change implementation activities with Engineering, Facilities, Quality, Validation, Manufacturing, and laboratory personnel.\n\nEnsure all required validation deliverables are completed prior to Change Control closure.\n\nSupport deviations, investigations, CAPAs, and corrective actions associated with qualification or temperature-controlled equipment.\n\nReview discrepancies encountered during protocol execution and assist with root-cause investigations.\n\nSupport calibration, preventive maintenance, alarm verification, and equipment lifecycle activities where applicable.\n\nEnsure equipment remains in a validated and compliant state following modifications, repairs, upgrades, or relocation.\n\nSupport periodic review and requalification programs for GMP equipment.\n\nMaintain accurate documentation in accordance with cGMP, GDP, data integrity, and site procedures.\n\nParticipate in inspection-readiness activities and support internal, client, and regulatory audits.\n\nRequired Qualifications\n\nBachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.\n\nApproximately 5+ years of validation, qualification, engineering, or quality experience within pharmaceutical, biotechnology, or another GMP-regulated environment.\n\nStrong hands‑on experience with Change Control / Change Management.\n\nHands‑on experience with stability chambers, freezers, refrigerators, cold rooms, or similar temperature‑controlled equipment.\n\nExperience developing and executing IQ/OQ/PQ protocols and qualification reports.\n\nUnderstanding of temperature mapping and controlled‑temperature equipment qualification.\n\nExperience performing validation impact assessments and risk assessments.\n\nFamiliarity with deviations, CAPAs, investigations, and GMP documentation.\n\nStrong knowledge of cGMP requirements and Good Documentation Practices.\n\nAbility to independently manage validation/change‑control deliverables and coordinate across multiple functional teams.\n\n#J-18808-Ljbffr","datePosted":"2026-09-25T03:47:41.908Z","dateModified":"2026-09-25T03:47:41.908Z","hiringOrganization":{"@type":"Organization","name":"United Pharma Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Millbrae","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9c9ef1b3d4e71ce177cf51ad"},"url":"https://jobsearcher.com/jobs/9c9ef1b3d4e71ce177cf51ad"}}