{"schemaVersion":"jobsearcher.job.v1","id":"56c0cc9d50fb2a5ecfca6332","url":"https://jobsearcher.com/jobs/56c0cc9d50fb2a5ecfca6332","canonicalUrl":"https://jobsearcher.com/jobs/56c0cc9d50fb2a5ecfca6332","title":"Sr. Validation Engineer","description":"Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation\n\nJob Summary\nThe Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems.\n\nKey Responsibilities\n\nLead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.\n\nCollaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.\n\nDevelop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.\n\nUtilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.\n\nProvide technical guidance and mentorship to junior validation engineers and contractors.\n\nSupport change control processes and deviation investigations related to validated systems.\n\nParticipate in audits and inspections, providing subject matter expertise on validation practices and documentation.\n\nEnsure alignment with the overall execution and resource plan as outlined in the C&Q strategy. [Cognizant...-June-2025 | PDF]\n\nRequired Qualifications\n\nBachelor's or Master's degree in Engineering, Life Sciences, or related field.\n\nMinimum 7+ years of experience in validation within the pharmaceutical or biotech industry.\n\nStrong knowledge of cGMP, FDA, ICH, and EU regulations.\n\nProven experience with commissioning and qualification of automation systems.\n\nProficiency in validation tools such as Kneat, GVault, or similar platforms.\n\nExcellent communication, documentation, and project coordination skills.\n\nPreferred Qualifications\n\nExperience working on large-scale C&Q projects in a regulated environment.\n\nFamiliarity with systems and validation practices is a plus.\n\nPMP or equivalent project management certification.\n\n#J-18808-Ljbffr","company":"TechDigital Group","rawCompany":"techdigital group","city":"Wilson","state":"NC","isRemote":false,"isActive":true,"createdAt":"2026-06-17T03:31:34.270Z","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":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Validation Engineer","description":"Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation\n\nJob Summary\nThe Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems.\n\nKey Responsibilities\n\nLead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.\n\nCollaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.\n\nDevelop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.\n\nUtilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.\n\nProvide technical guidance and mentorship to junior validation engineers and contractors.\n\nSupport change control processes and deviation investigations related to validated systems.\n\nParticipate in audits and inspections, providing subject matter expertise on validation practices and documentation.\n\nEnsure alignment with the overall execution and resource plan as outlined in the C&Q strategy. [Cognizant...-June-2025 | PDF]\n\nRequired Qualifications\n\nBachelor's or Master's degree in Engineering, Life Sciences, or related field.\n\nMinimum 7+ years of experience in validation within the pharmaceutical or biotech industry.\n\nStrong knowledge of cGMP, FDA, ICH, and EU regulations.\n\nProven experience with commissioning and qualification of automation systems.\n\nProficiency in validation tools such as Kneat, GVault, or similar platforms.\n\nExcellent communication, documentation, and project coordination skills.\n\nPreferred Qualifications\n\nExperience working on large-scale C&Q projects in a regulated environment.\n\nFamiliarity with systems and validation practices is a plus.\n\nPMP or equivalent project management certification.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:31:34.270Z","dateModified":"2026-06-17T03:31:34.270Z","hiringOrganization":{"@type":"Organization","name":"TechDigital Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wilson","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"56c0cc9d50fb2a5ecfca6332"},"url":"https://jobsearcher.com/jobs/56c0cc9d50fb2a5ecfca6332"}}