{"schemaVersion":"jobsearcher.job.v1","id":"3cf91a136eee5ffdb02b2a28","url":"https://jobsearcher.com/jobs/3cf91a136eee5ffdb02b2a28","canonicalUrl":"https://jobsearcher.com/jobs/3cf91a136eee5ffdb02b2a28","title":"CQV Engineer - Pharma","description":"Job Title: CQV Engineer - Pharma\r\nLocation: Devens, MA\r\nDuration: 6 - 12 Months\r\nPosition Overview:\r\nOur client is seeking CQV Engineers to support an NPD large-cap project involving modification of existing equipment and processes for future methods within an existing large-scale cell culture facility. These resources will focus on process equipment qualification execution, including walking systems down, executing qualification protocols.\r\nKey Responsibilities:\r\nExecute IQ/OQ and traditional qualification protocols for process equipment\r\nPerform field walkdowns and verify drawings against installed configurations\r\nVerify maintenance systems, process flow paths, and functional design requirements\r\nExecute wet testing and operational verification activities\r\nSupport SIP/CIP cycle development in coordination with Manufacturing Engineering\r\nPerform post-IQ/OQ qualification activities including:\r\nSteam-in-place temperature mapping\r\nBiological Indicator (BI) placement/retrieval\r\nProcess data collection and QC lab report coordination\r\nGenerate, execute, and report validation documentation inValGenesis\r\nSupport compressed project timelines across multi-shift execution schedules\r\nRequired Qualifications:\r\nStrong CQV / Validation Execution experience with process equipment\r\nHands-on experience executing IQ/OQ protocols\r\nAbility to work independently while maintaining alignment with team/project goals\r\nExperience with ValGenesis or similar e-validation platforms\r\nStrong GDP/documentation practices\r\nRequired Technical Experience:\r\nDownstream biologics equipment qualification/validation execution experience\r\nExperience with: Harvest Clarification Equipment, Viral Filtration Equipment, Ultrafiltration Systems, Buffer Transfer Equipment, Tank Farms, Chromatography Systems, Steam Clean-in-Place / SIP / CIP activities, Large-scale biologics/cell culture manufacturing environments\r\nPreferred Background:\r\n4–7 years of relevant CQV/Validation experience\r\nExperience in large-scale biologics manufacturing\r\nPrior work in GMP cell culture facilities","company":"Intellectt","rawCompany":"intellectt","city":"Devens","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-05-10T01:30:49.831Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"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":"CQV Engineer - Pharma","description":"Job Title: CQV Engineer - Pharma\r\nLocation: Devens, MA\r\nDuration: 6 - 12 Months\r\nPosition Overview:\r\nOur client is seeking CQV Engineers to support an NPD large-cap project involving modification of existing equipment and processes for future methods within an existing large-scale cell culture facility. These resources will focus on process equipment qualification execution, including walking systems down, executing qualification protocols.\r\nKey Responsibilities:\r\nExecute IQ/OQ and traditional qualification protocols for process equipment\r\nPerform field walkdowns and verify drawings against installed configurations\r\nVerify maintenance systems, process flow paths, and functional design requirements\r\nExecute wet testing and operational verification activities\r\nSupport SIP/CIP cycle development in coordination with Manufacturing Engineering\r\nPerform post-IQ/OQ qualification activities including:\r\nSteam-in-place temperature mapping\r\nBiological Indicator (BI) placement/retrieval\r\nProcess data collection and QC lab report coordination\r\nGenerate, execute, and report validation documentation inValGenesis\r\nSupport compressed project timelines across multi-shift execution schedules\r\nRequired Qualifications:\r\nStrong CQV / Validation Execution experience with process equipment\r\nHands-on experience executing IQ/OQ protocols\r\nAbility to work independently while maintaining alignment with team/project goals\r\nExperience with ValGenesis or similar e-validation platforms\r\nStrong GDP/documentation practices\r\nRequired Technical Experience:\r\nDownstream biologics equipment qualification/validation execution experience\r\nExperience with: Harvest Clarification Equipment, Viral Filtration Equipment, Ultrafiltration Systems, Buffer Transfer Equipment, Tank Farms, Chromatography Systems, Steam Clean-in-Place / SIP / CIP activities, Large-scale biologics/cell culture manufacturing environments\r\nPreferred Background:\r\n4–7 years of relevant CQV/Validation experience\r\nExperience in large-scale biologics manufacturing\r\nPrior work in GMP cell culture facilities","datePosted":"2026-05-10T01:30:49.831Z","dateModified":"2026-05-10T01:30:49.831Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Devens","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3cf91a136eee5ffdb02b2a28"},"url":"https://jobsearcher.com/jobs/3cf91a136eee5ffdb02b2a28"}}