{"schemaVersion":"jobsearcher.job.v1","id":"48f14ff8bae5221171e31368","url":"https://jobsearcher.com/jobs/48f14ff8bae5221171e31368","canonicalUrl":"https://jobsearcher.com/jobs/48f14ff8bae5221171e31368","title":"Computer System Validation (CSV) Specialist (EBR System)","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:\nComputer System Validation (CSV) Specialist\nProject summary:\nValidate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements.\nScope of work:\nDevelop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch records, and batch execution.\nConfirm system requirements, risk assessment, and traceability for recipe data, electronic signatures, audit trails, and change control.\nPerform vendor/system assessments, GAP analysis, and mapping to regulatory controls.\nCreate/execute validation artifacts: URS, VRA, FRS/SRS (if applicable), DQ/IQ/OQ/PQ (or equivalent), test scripts, test execution results, traceability matrix, validation summary report.\nSupport configuration, data migration/verification of recipe records, user acceptance testing, and remediation/defect closure.\nProvide CSV support during go-live and initial production batches, and handover to QA/IT for periodic review.\nDeliverables:\nValidation project plan and schedule\nRequirements traceability matrix (RTM)\nRisk assessment (e.g., FMEA/Hazard analysis for recipes)\nDesign qualification (DQ) report\nInstallation qualification (IQ) procedures & reports\nOperational qualification (OQ) procedures & reports (including negative/edge cases for recipe execution)\nPerformance qualification (PQ) scripts & reports (including sample batch runs)\nTest scripts and executed test evidence, incl. electronic signature and audit trail verification\nData migration plan and verification evidence for recipe/master records\nValidation summary report and final sign-off package\nSOP/Work instruction reviews and CSV-related training materials\nPost-implementation validation support\nResource profile / qualifications:\nCSV specialist with 5+ years experience validating EBR/EVRS systems in regulated pharma/biotech/medical devices.\nExperience with 21 CFR Part 11, EU Annex 11, GMP, and applicable GCP/GLP as needed.\nHands-on experience writing/executing IQ/OQ/PQ and creating traceability matrices.\nExperience with recipe management, MES/SCADA/ERP integrations, and data migration for master recipes.\nPreferred:\nComputer science/engineering or life-science degree; certification(s) such as ASQ, ISPE, or vendor-specific EVRS experience.\nAvailable to work additional hours and weeks-ends if required at certain time\nFirst shift project\nOn site project\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","company":"Validation","rawCompany":"validation","city":"Westfield","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-08-03T22:20:27.762Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"}],"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":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation (CSV) Specialist (EBR System)","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:\nComputer System Validation (CSV) Specialist\nProject summary:\nValidate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements.\nScope of work:\nDevelop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch records, and batch execution.\nConfirm system requirements, risk assessment, and traceability for recipe data, electronic signatures, audit trails, and change control.\nPerform vendor/system assessments, GAP analysis, and mapping to regulatory controls.\nCreate/execute validation artifacts: URS, VRA, FRS/SRS (if applicable), DQ/IQ/OQ/PQ (or equivalent), test scripts, test execution results, traceability matrix, validation summary report.\nSupport configuration, data migration/verification of recipe records, user acceptance testing, and remediation/defect closure.\nProvide CSV support during go-live and initial production batches, and handover to QA/IT for periodic review.\nDeliverables:\nValidation project plan and schedule\nRequirements traceability matrix (RTM)\nRisk assessment (e.g., FMEA/Hazard analysis for recipes)\nDesign qualification (DQ) report\nInstallation qualification (IQ) procedures & reports\nOperational qualification (OQ) procedures & reports (including negative/edge cases for recipe execution)\nPerformance qualification (PQ) scripts & reports (including sample batch runs)\nTest scripts and executed test evidence, incl. electronic signature and audit trail verification\nData migration plan and verification evidence for recipe/master records\nValidation summary report and final sign-off package\nSOP/Work instruction reviews and CSV-related training materials\nPost-implementation validation support\nResource profile / qualifications:\nCSV specialist with 5+ years experience validating EBR/EVRS systems in regulated pharma/biotech/medical devices.\nExperience with 21 CFR Part 11, EU Annex 11, GMP, and applicable GCP/GLP as needed.\nHands-on experience writing/executing IQ/OQ/PQ and creating traceability matrices.\nExperience with recipe management, MES/SCADA/ERP integrations, and data migration for master recipes.\nPreferred:\nComputer science/engineering or life-science degree; certification(s) such as ASQ, ISPE, or vendor-specific EVRS experience.\nAvailable to work additional hours and weeks-ends if required at certain time\nFirst shift project\nOn site project\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","datePosted":"2026-08-03T22:20:27.762Z","dateModified":"2026-08-03T22:20:27.762Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Westfield","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"48f14ff8bae5221171e31368"},"url":"https://jobsearcher.com/jobs/48f14ff8bae5221171e31368"}}