{"schemaVersion":"jobsearcher.job.v1","id":"43f48540a40867424b57b747","url":"https://jobsearcher.com/jobs/43f48540a40867424b57b747","canonicalUrl":"https://jobsearcher.com/jobs/43f48540a40867424b57b747","title":"Lead Validation Engineer","description":"Top 3 Must Have's:\r\nLife science Domain, Validation Skills, Delta V & MES Validation\r\nJob Summary\r\nThe Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders.\r\nKey Responsibilities\r\nLead the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems.\r\nDevelop and implement validation strategies in alignment with quality standards and global regulatory requirements.\r\nServe as the primary point of contact for validation-related matters across engineering, QA, manufacturing, and automation teams.\r\nReview and approve validation protocols, reports, and supporting documentation.\r\nManage validation timelines, resource allocation, and risk mitigation plans.\r\nProvide technical leadership and mentorship to validation engineers and contractors.\r\nSupport audits and inspections by presenting validation documentation and processes.\r\nEnsure compliance with cGMP, FDA, EU, and internal quality standards.\r\nRequired Qualifications\r\nBachelor's or Master's degree in Engineering, Life Sciences, or related field.\r\n10+ years of experience in validation within the pharmaceutical or biotech industry.\r\nDemonstrated leadership in managing C&Q projects and teams.\r\nDeep understanding of regulatory requirements and industry best practices.\r\nProficiency with validation tools such as Kneat, GVault, or equivalent.\r\nStrong communication, organizational, and stakeholder management skills.\r\nPreferred Qualifications\r\nExperience with large-scale C&Q projects in regulated environments.\r\nPMP or equivalent project management certification.\r\nPrior experience leading validation efforts in greenfield or brownfield projects.\r\nJ-18808-Ljbffr","company":"TechDigital Group","rawCompany":"techdigital group","city":"Wilson","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-06-19T00:49:36.626Z","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":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Validation Engineer","description":"Top 3 Must Have's:\r\nLife science Domain, Validation Skills, Delta V & MES Validation\r\nJob Summary\r\nThe Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders.\r\nKey Responsibilities\r\nLead the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems.\r\nDevelop and implement validation strategies in alignment with quality standards and global regulatory requirements.\r\nServe as the primary point of contact for validation-related matters across engineering, QA, manufacturing, and automation teams.\r\nReview and approve validation protocols, reports, and supporting documentation.\r\nManage validation timelines, resource allocation, and risk mitigation plans.\r\nProvide technical leadership and mentorship to validation engineers and contractors.\r\nSupport audits and inspections by presenting validation documentation and processes.\r\nEnsure compliance with cGMP, FDA, EU, and internal quality standards.\r\nRequired Qualifications\r\nBachelor's or Master's degree in Engineering, Life Sciences, or related field.\r\n10+ years of experience in validation within the pharmaceutical or biotech industry.\r\nDemonstrated leadership in managing C&Q projects and teams.\r\nDeep understanding of regulatory requirements and industry best practices.\r\nProficiency with validation tools such as Kneat, GVault, or equivalent.\r\nStrong communication, organizational, and stakeholder management skills.\r\nPreferred Qualifications\r\nExperience with large-scale C&Q projects in regulated environments.\r\nPMP or equivalent project management certification.\r\nPrior experience leading validation efforts in greenfield or brownfield projects.\r\nJ-18808-Ljbffr","datePosted":"2026-06-19T00:49:36.626Z","dateModified":"2026-06-19T00:49:36.626Z","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":"43f48540a40867424b57b747"},"url":"https://jobsearcher.com/jobs/43f48540a40867424b57b747"}}