{"schemaVersion":"jobsearcher.job.v1","id":"d9c98fc5634b2e409fb198bb","url":"https://jobsearcher.com/jobs/d9c98fc5634b2e409fb198bb","canonicalUrl":"https://jobsearcher.com/jobs/d9c98fc5634b2e409fb198bb","title":"CSV Engineer","description":"Job Description\n\nThe CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).\n\nThis role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.\n\nBy maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.\n\nRoles & Responsibilities\n\nAuthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.\n\nSupport computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).\n\nPerform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.\n\nManage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.\n\nCollaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.\n\nRequirements\n\nBachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).\n\n5–7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).\n\nWorking knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).\n\nExperience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.\n\nStrong technical writing skills and ability to execute protocols with minimal supervision.\n\nNice to have: BMRAM and analytical lab instruments experience.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Dayton","state":"OH","isRemote":false,"isActive":false,"createdAt":"2026-06-26T05:09:36.483Z","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":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"}],"industries":[{"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"},{"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":"CSV Engineer","description":"Job Description\n\nThe CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).\n\nThis role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.\n\nBy maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.\n\nRoles & Responsibilities\n\nAuthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.\n\nSupport computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).\n\nPerform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.\n\nManage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.\n\nCollaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.\n\nRequirements\n\nBachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).\n\n5–7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).\n\nWorking knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).\n\nExperience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.\n\nStrong technical writing skills and ability to execute protocols with minimal supervision.\n\nNice to have: BMRAM and analytical lab instruments experience.\n\n#J-18808-Ljbffr","datePosted":"2026-06-26T05:09:36.483Z","dateModified":"2026-06-26T05:09:36.483Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dayton","addressRegion":"OH","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"d9c98fc5634b2e409fb198bb"},"url":"https://jobsearcher.com/jobs/d9c98fc5634b2e409fb198bb"}}