{"schemaVersion":"jobsearcher.job.v1","id":"b600a1fcd87f8fdbb00bef7e","url":"https://jobsearcher.com/jobs/b600a1fcd87f8fdbb00bef7e","canonicalUrl":"https://jobsearcher.com/jobs/b600a1fcd87f8fdbb00bef7e","title":"CSV Lead","description":"Roles & Responsibilities:Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition).Perform ERP validation, Data Migration, and Cloud Validation activities.Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs).Ensure compliance with GxP, FDA regulations, and risk-based validation.Support Acquisitions, Divestitures, and Business Separation projects.Demonstrate strong leadership and stakeholder communication.Requirements:7 10+ years of experience in Computer System Validation (CSV).Experience in Pharmaceutical / Biotechnology / Medical Device industry.","company":"Karwell Technologies","rawCompany":"karwell technologies","city":"Somerville","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-05-21T03:20:08.462Z","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":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"}],"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":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Lead","description":"Roles & Responsibilities:Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition).Perform ERP validation, Data Migration, and Cloud Validation activities.Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs).Ensure compliance with GxP, FDA regulations, and risk-based validation.Support Acquisitions, Divestitures, and Business Separation projects.Demonstrate strong leadership and stakeholder communication.Requirements:7 10+ years of experience in Computer System Validation (CSV).Experience in Pharmaceutical / Biotechnology / Medical Device industry.","datePosted":"2026-05-21T03:20:08.462Z","dateModified":"2026-05-21T03:20:08.462Z","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":"b600a1fcd87f8fdbb00bef7e"},"url":"https://jobsearcher.com/jobs/b600a1fcd87f8fdbb00bef7e"}}