{"schemaVersion":"jobsearcher.job.v1","id":"533bdcb929e89d7aa4da56ec","url":"https://jobsearcher.com/jobs/533bdcb929e89d7aa4da56ec","canonicalUrl":"https://jobsearcher.com/jobs/533bdcb929e89d7aa4da56ec","title":"CSV Engineer","description":"Roles & Responsibilities:Lead end-to-end CSV activities (inventory assessment remediation disposition).Support business separation for large GxP systems.Define & implement risk-based validation strategies.Review & approve test plans, UAT scripts, validation documents.Ensure compliance with regulatory & quality standards.Provide guidance, escalation & leadership to validation teams.Collaborate with global & remote teams.Requirements:7 10 years in CSV / Validation roles.Experience in Pharma / Biotech / Medical Devices industry.Proven experience in regulated environments (FDA/GxP).Strong expertise in CSV (Computer System Validation) in GxP environments.Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation).Hands-on in Acquisitions / Divestitures / Business Separation projects.Deep understanding of FDA regulations & GxP standards.Experience with Risk-based validation approach.Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs).Experience in UAT, Traceability Matrix & QA methodologies.Ability to lead teams & manage multiple projects.","company":"Karwell Technologies","rawCompany":"karwell technologies","city":"Somerville","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-05-21T03:20:08.465Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"}],"industries":[{"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"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Engineer","description":"Roles & Responsibilities:Lead end-to-end CSV activities (inventory assessment remediation disposition).Support business separation for large GxP systems.Define & implement risk-based validation strategies.Review & approve test plans, UAT scripts, validation documents.Ensure compliance with regulatory & quality standards.Provide guidance, escalation & leadership to validation teams.Collaborate with global & remote teams.Requirements:7 10 years in CSV / Validation roles.Experience in Pharma / Biotech / Medical Devices industry.Proven experience in regulated environments (FDA/GxP).Strong expertise in CSV (Computer System Validation) in GxP environments.Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation).Hands-on in Acquisitions / Divestitures / Business Separation projects.Deep understanding of FDA regulations & GxP standards.Experience with Risk-based validation approach.Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs).Experience in UAT, Traceability Matrix & QA methodologies.Ability to lead teams & manage multiple projects.","datePosted":"2026-05-21T03:20:08.465Z","dateModified":"2026-05-21T03:20:08.465Z","hiringOrganization":{"@type":"Organization","name":"Karwell Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerville","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"533bdcb929e89d7aa4da56ec"},"url":"https://jobsearcher.com/jobs/533bdcb929e89d7aa4da56ec"}}