{"schemaVersion":"jobsearcher.job.v1","id":"6605cfc60aa141ff77d99982","url":"https://jobsearcher.com/jobs/6605cfc60aa141ff77d99982","canonicalUrl":"https://jobsearcher.com/jobs/6605cfc60aa141ff77d99982","title":"Lead Validation Engineer","description":"Lead Validation Engineer – Katalyst CRO, Devens, MA\n\nJoin to apply for the Lead Validation Engineer role at Katalyst CRO. This position supports validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment.\n\nRoles & Responsibilities\n\nDevelop and execute validation strategies for cleaning processes, utilities, laboratory equipment, and manufacturing systems in alignment with cGMP, site requirements, and industry standards.\n\nAuthor and execute Cleaning Validation, Clean Hold Time, Dirty Hold Time, Cycle Development, and Equipment Qualification (IQ/OQ/PQ) protocols.\n\nLead CQV activities for new and existing equipment, ensuring compliance with URS, engineering specifications, and manufacturer recommendations.\n\nWrite, review, and approve validation documents including protocols, summary reports, design documents, SOPs, batch records, and technical evaluations.\n\nCreate and manage deviations, change controls, investigations, and CAPAs as part of ongoing validation and operational support.\n\nEnsure documentation accuracy, completeness, and alignment with regulatory expectations.\n\nTroubleshoot and investigate validation protocol exceptions, OOS/OOT results, equipment failures, and cleaning discrepancies.\n\nConduct root cause analyses and develop corrective and preventive actions to prevent recurrence.\n\nCollaborate with QA, Engineering, Manufacturing, and Validation leadership to drive timely closure of investigations.\n\nSupport technology transfer activities, including review of process requirements, generation of process flow diagrams, and gap analyses.\n\nProvide on-the-floor support during manufacturing, assisting with real-time troubleshooting of processing issues.\n\nParticipate in creation and optimization of electronic batch records (eBR) and in-process sampling plans.\n\nAnalyze manufacturing and validation data to identify process improvements and optimize system performance.\n\nPartner with departments including Quality Assurance, Validation, Manufacturing, Process Development, Engineering, and Program Management to ensure successful project execution.\n\nFacilitate system release and handover to end users following completion of qualification activities.\n\nProvide clear communication of project status, risks, and deliverables to stakeholders.\n\nSupport regulatory inspections, internal audits, and client audits, providing expertise for cleaning validation, equipment qualification, and site validation programs.\n\nMaintain adherence to FDA, EMA, and ICH guidelines as well as internal site procedures.\n\nEducation & Experience\n\nBachelor's degree in Biochemistry, Chemical Engineering, Life Sciences, or related scientific or engineering discipline.\n\n8+ years of experience in validation, CQV, quality assurance, tech transfer, or manufacturing within a GMP-regulated biopharmaceutical environment.\n\nExpertise in cleaning validation, equipment qualification, utility qualification, deviation investigations, CAPA development, and authoring protocols, reports, batch records, and design documents.\n\nStrong working knowledge of FDA, ICH, and GMP regulations.\n\nExperience with large-scale biologics manufacturing equipment (e.g., bioreactors, process vessels, chromatography/UFDF skids, single-use systems).\n\nExperience supporting technology transfer activities.\n\nExperience with electronic systems such as eBR, QMS platforms, and data analysis tools.\n\nStrong problem-solving and analytical skills.\n\nHigh attention to detail and documentation rigor.\n\nAbility to manage multiple projects in a fast-paced environment.\n\nEffective communicator with strong cross‑functional leadership abilities.\n\nFlexible, reliable, and committed to delivering high-quality work.\n\nJob Details\nLocation: Devens, MA (other locations available)\n\nEmployment Type: Contract\n\nSeniority Level: Mid‑Senior level\n\n#J-18808-Ljbffr","company":"Katalyst CRO","rawCompany":"katalyst cro","city":"Harvard","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-09T09:06:26.312Z","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":"Lead Validation Engineer","description":"Lead Validation Engineer – Katalyst CRO, Devens, MA\n\nJoin to apply for the Lead Validation Engineer role at Katalyst CRO. This position supports validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment.\n\nRoles & Responsibilities\n\nDevelop and execute validation strategies for cleaning processes, utilities, laboratory equipment, and manufacturing systems in alignment with cGMP, site requirements, and industry standards.\n\nAuthor and execute Cleaning Validation, Clean Hold Time, Dirty Hold Time, Cycle Development, and Equipment Qualification (IQ/OQ/PQ) protocols.\n\nLead CQV activities for new and existing equipment, ensuring compliance with URS, engineering specifications, and manufacturer recommendations.\n\nWrite, review, and approve validation documents including protocols, summary reports, design documents, SOPs, batch records, and technical evaluations.\n\nCreate and manage deviations, change controls, investigations, and CAPAs as part of ongoing validation and operational support.\n\nEnsure documentation accuracy, completeness, and alignment with regulatory expectations.\n\nTroubleshoot and investigate validation protocol exceptions, OOS/OOT results, equipment failures, and cleaning discrepancies.\n\nConduct root cause analyses and develop corrective and preventive actions to prevent recurrence.\n\nCollaborate with QA, Engineering, Manufacturing, and Validation leadership to drive timely closure of investigations.\n\nSupport technology transfer activities, including review of process requirements, generation of process flow diagrams, and gap analyses.\n\nProvide on-the-floor support during manufacturing, assisting with real-time troubleshooting of processing issues.\n\nParticipate in creation and optimization of electronic batch records (eBR) and in-process sampling plans.\n\nAnalyze manufacturing and validation data to identify process improvements and optimize system performance.\n\nPartner with departments including Quality Assurance, Validation, Manufacturing, Process Development, Engineering, and Program Management to ensure successful project execution.\n\nFacilitate system release and handover to end users following completion of qualification activities.\n\nProvide clear communication of project status, risks, and deliverables to stakeholders.\n\nSupport regulatory inspections, internal audits, and client audits, providing expertise for cleaning validation, equipment qualification, and site validation programs.\n\nMaintain adherence to FDA, EMA, and ICH guidelines as well as internal site procedures.\n\nEducation & Experience\n\nBachelor's degree in Biochemistry, Chemical Engineering, Life Sciences, or related scientific or engineering discipline.\n\n8+ years of experience in validation, CQV, quality assurance, tech transfer, or manufacturing within a GMP-regulated biopharmaceutical environment.\n\nExpertise in cleaning validation, equipment qualification, utility qualification, deviation investigations, CAPA development, and authoring protocols, reports, batch records, and design documents.\n\nStrong working knowledge of FDA, ICH, and GMP regulations.\n\nExperience with large-scale biologics manufacturing equipment (e.g., bioreactors, process vessels, chromatography/UFDF skids, single-use systems).\n\nExperience supporting technology transfer activities.\n\nExperience with electronic systems such as eBR, QMS platforms, and data analysis tools.\n\nStrong problem-solving and analytical skills.\n\nHigh attention to detail and documentation rigor.\n\nAbility to manage multiple projects in a fast-paced environment.\n\nEffective communicator with strong cross‑functional leadership abilities.\n\nFlexible, reliable, and committed to delivering high-quality work.\n\nJob Details\nLocation: Devens, MA (other locations available)\n\nEmployment Type: Contract\n\nSeniority Level: Mid‑Senior level\n\n#J-18808-Ljbffr","datePosted":"2026-04-09T09:06:26.312Z","dateModified":"2026-04-09T09:06:26.312Z","hiringOrganization":{"@type":"Organization","name":"Katalyst CRO","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6605cfc60aa141ff77d99982"},"url":"https://jobsearcher.com/jobs/6605cfc60aa141ff77d99982"}}