{"schemaVersion":"jobsearcher.job.v1","id":"f25346dde7f61ba60a3430f9","url":"https://jobsearcher.com/jobs/f25346dde7f61ba60a3430f9","canonicalUrl":"https://jobsearcher.com/jobs/f25346dde7f61ba60a3430f9","title":"Cleaning Validation Engineer","description":"As a Cleaning Validation Engineer, you will be responsible for developing and executing validation strategies to ensure equipment and processes comply with domestic and international GMP regulations.\n\nYou will create and maintain validation lifecycle documentation, perform technical assessments, and collaborate with cross-functional teams to support smooth and compliant manufacturing operations.\n\nValidation Strategy and Documentation\nDevelop comprehensive validation strategies for cleaning and sterilization processes.\n\nCreate and maintain validation lifecycle documentation, including IQ/OQ/PQ protocols, risk assessments, traceability matrices, and validation reports.\n\nReview and approve validation deliverables such as project plans, protocols, reports, and test scripts.\n\nLead continuous improvement initiatives in validation practices and procedures across facilities.\n\nImplement best practices for validation programs to ensure consistency and compliance across projects.\n\nTechnical and Quality Support\nProvide technical assessments for CAPA, deviation, and change control management activities.\n\nTroubleshoot cleaning and steam sterilization issues to maintain efficient manufacturing operations.\n\nSupport new product rollouts by validating systems and processes during Tech Transfer.\n\nRepresent the organization in contractual and project discussions, interacting with senior internal and external stakeholders.\n\nProvide validation expertise to Regulatory Affairs when addressing governmental or compliance inquiries.\n\nCross-Functional Collaboration\nWork closely with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to ensure all validation deliverables align with project scope and timelines.\n\nCollaborate to define project objectives, establish timelines, and ensure adherence to validation policies.\n\nRequired Skills\n\nBachelor’s degree in Industrial Chemical Engineering, Chemical Engineering, or a related discipline.\n\nMinimum 2+ years of experience in cleaning validation or related GMP manufacturing environments.\n\nProven experience preparing Cleaning Validation Plans aligned with organizational policies.\n\nSkilled in developing and executing Cleaning Risk Assessments for new or modified product introductions based on toxicology data.\n\nHands-on experience developing and executing Cleaning Validation (CV) testing protocols for CIP (Clean-in-Place) and COP (Clean-Out-of-Place) systems.\n\nStrong knowledge of IQ/OQ/PQ qualification protocols for autoclaves, Steam-in-Place (SIP) systems, and other GMP equipment.\n\nExcellent communication, documentation, and cross-functional collaboration skills.\n\nUpload Resume {{ resumeFile ?resumeFile.name.slice(0,7)+resumeFile.name.slice(resumeFile.name.length-8,):\"No file chosen\" }}\n\n#J-18808-Ljbffr","company":"Ushitecsolutions","rawCompany":"ushitecsolutions","city":"Raleigh","state":"NC","isRemote":false,"isActive":true,"createdAt":"2026-06-17T04:17:05.330Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"31-9093.00","title":"Medical Equipment Preparers","slug":"medical-equipment-preparers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Cleaning Validation Engineer","description":"As a Cleaning Validation Engineer, you will be responsible for developing and executing validation strategies to ensure equipment and processes comply with domestic and international GMP regulations.\n\nYou will create and maintain validation lifecycle documentation, perform technical assessments, and collaborate with cross-functional teams to support smooth and compliant manufacturing operations.\n\nValidation Strategy and Documentation\nDevelop comprehensive validation strategies for cleaning and sterilization processes.\n\nCreate and maintain validation lifecycle documentation, including IQ/OQ/PQ protocols, risk assessments, traceability matrices, and validation reports.\n\nReview and approve validation deliverables such as project plans, protocols, reports, and test scripts.\n\nLead continuous improvement initiatives in validation practices and procedures across facilities.\n\nImplement best practices for validation programs to ensure consistency and compliance across projects.\n\nTechnical and Quality Support\nProvide technical assessments for CAPA, deviation, and change control management activities.\n\nTroubleshoot cleaning and steam sterilization issues to maintain efficient manufacturing operations.\n\nSupport new product rollouts by validating systems and processes during Tech Transfer.\n\nRepresent the organization in contractual and project discussions, interacting with senior internal and external stakeholders.\n\nProvide validation expertise to Regulatory Affairs when addressing governmental or compliance inquiries.\n\nCross-Functional Collaboration\nWork closely with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to ensure all validation deliverables align with project scope and timelines.\n\nCollaborate to define project objectives, establish timelines, and ensure adherence to validation policies.\n\nRequired Skills\n\nBachelor’s degree in Industrial Chemical Engineering, Chemical Engineering, or a related discipline.\n\nMinimum 2+ years of experience in cleaning validation or related GMP manufacturing environments.\n\nProven experience preparing Cleaning Validation Plans aligned with organizational policies.\n\nSkilled in developing and executing Cleaning Risk Assessments for new or modified product introductions based on toxicology data.\n\nHands-on experience developing and executing Cleaning Validation (CV) testing protocols for CIP (Clean-in-Place) and COP (Clean-Out-of-Place) systems.\n\nStrong knowledge of IQ/OQ/PQ qualification protocols for autoclaves, Steam-in-Place (SIP) systems, and other GMP equipment.\n\nExcellent communication, documentation, and cross-functional collaboration skills.\n\nUpload Resume {{ resumeFile ?resumeFile.name.slice(0,7)+resumeFile.name.slice(resumeFile.name.length-8,):\"No file chosen\" }}\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:17:05.330Z","dateModified":"2026-06-17T04:17:05.330Z","hiringOrganization":{"@type":"Organization","name":"Ushitecsolutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raleigh","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f25346dde7f61ba60a3430f9"},"url":"https://jobsearcher.com/jobs/f25346dde7f61ba60a3430f9"}}