{"schemaVersion":"jobsearcher.job.v1","id":"64d38c4630a07150c3a61ae9","url":"https://jobsearcher.com/jobs/64d38c4630a07150c3a61ae9","canonicalUrl":"https://jobsearcher.com/jobs/64d38c4630a07150c3a61ae9","title":"CSV Analyst","description":"Job Title: Computer System Validation (CSV) AnalystLocation: Concord Manufacturing Site (Onsite) Employment Type: [Long term Contract]OverviewWe are seeking a Computer System Validation (CSV) Analyst to support a newer manufacturing site in Concord. This role will be responsible for the creation, execution, and maintenance of site-level CSV documentation and validation deliverables in a regulated GMP environment. The ideal candidate has hands-on experience validating manufacturing and quality systems and is comfortable supporting a growing site with developing processes.Key ResponsibilitiesOwn the creation, maintenance, and lifecycle management of local CSV validation deliverables for the Concord siteAuthor site-level validation documentation, including:Site Validation Agreements and Validation ReportsSecurity Plan and Security Administration documentationBusiness Continuity Plan (BCP) and Disaster Recovery Plan (DRP)Develop and execute Installation Verification Instructions (IVI) and IQ/OQ documentation for validated systemsCreate and maintain validation Test Plans as required based on system risk and GxP impactAuthor and execute ALM test scripts, ensuring full traceability to requirementsSupport quality and IT processes by utilizing ServiceNow and TrackWise to manage:Change RequestsIncidentsDeviations / ProblemsPartner cross-functionally with IT, Quality, Engineering, and Manufacturing teams to support system implementations and changesEnsure all validation activities comply with applicable regulations (21 CFR Part 11, GAMP 5, internal SOPs)Required QualificationsBachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline (or equivalent experience)2+ years of hands-on Computer System Validation (CSV) experience in a regulated manufacturing environment (pharma, biotech, medical device, etc.)Strong experience authoring CSV documentation (IQ/OQ, test scripts, validation plans, reports)Working knowledge of ServiceNow and TrackWise (change management, incidents, and problem resolution)Familiarity with ALM tools for test script managementUnderstanding of GxP, data integrity, and 21 CFR Part 11 requirementsStrong documentation skills and attention to detailNice to HaveExperience supporting startup or greenfield manufacturing sitesExposure to MES, LIMS, ERP, or manufacturing automation systemsPrior experience helping establish or mature CSV processes at a new siteWhat Success Looks LikeValidation documentation is audit‑ready and aligned with regulatory and internal standardsSystems are validated efficiently without delaying operations at a growing siteStrong collaboration with Quality and IT stakeholders during system changes and implementations","company":"Brooksource","rawCompany":"brooksource","city":"Concord","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-04-24T13:26:02.416Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-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":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Analyst","description":"Job Title: Computer System Validation (CSV) AnalystLocation: Concord Manufacturing Site (Onsite) Employment Type: [Long term Contract]OverviewWe are seeking a Computer System Validation (CSV) Analyst to support a newer manufacturing site in Concord. This role will be responsible for the creation, execution, and maintenance of site-level CSV documentation and validation deliverables in a regulated GMP environment. The ideal candidate has hands-on experience validating manufacturing and quality systems and is comfortable supporting a growing site with developing processes.Key ResponsibilitiesOwn the creation, maintenance, and lifecycle management of local CSV validation deliverables for the Concord siteAuthor site-level validation documentation, including:Site Validation Agreements and Validation ReportsSecurity Plan and Security Administration documentationBusiness Continuity Plan (BCP) and Disaster Recovery Plan (DRP)Develop and execute Installation Verification Instructions (IVI) and IQ/OQ documentation for validated systemsCreate and maintain validation Test Plans as required based on system risk and GxP impactAuthor and execute ALM test scripts, ensuring full traceability to requirementsSupport quality and IT processes by utilizing ServiceNow and TrackWise to manage:Change RequestsIncidentsDeviations / ProblemsPartner cross-functionally with IT, Quality, Engineering, and Manufacturing teams to support system implementations and changesEnsure all validation activities comply with applicable regulations (21 CFR Part 11, GAMP 5, internal SOPs)Required QualificationsBachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline (or equivalent experience)2+ years of hands-on Computer System Validation (CSV) experience in a regulated manufacturing environment (pharma, biotech, medical device, etc.)Strong experience authoring CSV documentation (IQ/OQ, test scripts, validation plans, reports)Working knowledge of ServiceNow and TrackWise (change management, incidents, and problem resolution)Familiarity with ALM tools for test script managementUnderstanding of GxP, data integrity, and 21 CFR Part 11 requirementsStrong documentation skills and attention to detailNice to HaveExperience supporting startup or greenfield manufacturing sitesExposure to MES, LIMS, ERP, or manufacturing automation systemsPrior experience helping establish or mature CSV processes at a new siteWhat Success Looks LikeValidation documentation is audit‑ready and aligned with regulatory and internal standardsSystems are validated efficiently without delaying operations at a growing siteStrong collaboration with Quality and IT stakeholders during system changes and implementations","datePosted":"2026-04-24T13:26:02.416Z","dateModified":"2026-04-24T13:26:02.416Z","hiringOrganization":{"@type":"Organization","name":"Brooksource","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Concord","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"64d38c4630a07150c3a61ae9"},"url":"https://jobsearcher.com/jobs/64d38c4630a07150c3a61ae9"}}