{"schemaVersion":"jobsearcher.job.v1","id":"066f98caeb005c2da85c70f3","url":"https://jobsearcher.com/jobs/066f98caeb005c2da85c70f3","canonicalUrl":"https://jobsearcher.com/jobs/066f98caeb005c2da85c70f3","title":"Computer System Validation (CSV)","description":"Csv ConsultantLocation: Raritan, NJ (Hybrid)The ideal candidate will have 5+ years of computer system validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, S, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.Demonstrated delivery experience with generative AI and agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.Experience in the pharmaceutical, biotechnology, or medical device industry.Experience in FDA and/or global regulated environment with a good understanding of GxP standards and risk-based validation.Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports).Experience in reviewing system test and user acceptance test scripts, traceability matrix, and design specs.Experience in QA methodologies, designing, reviewing, and approving test plans, system/UAT test scripts, and test procedures.Strong verbal and written communication skills.Ability to work as a team player, lead a team, or accomplish tasks without supervision.Ability to work with remote teams and support several changes/projects simultaneously.Ability to provide validation guidance, timely reviews, and escalations to TQ management.","company":"Resource Logistics","rawCompany":"resource logistics","city":"Denver","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-09-11T13:00:22.438Z","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":"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":"541618","title":"Other Management Consulting Services","slug":"other-management-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation (CSV)","description":"Csv ConsultantLocation: Raritan, NJ (Hybrid)The ideal candidate will have 5+ years of computer system validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, S, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.Demonstrated delivery experience with generative AI and agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.Experience in the pharmaceutical, biotechnology, or medical device industry.Experience in FDA and/or global regulated environment with a good understanding of GxP standards and risk-based validation.Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports).Experience in reviewing system test and user acceptance test scripts, traceability matrix, and design specs.Experience in QA methodologies, designing, reviewing, and approving test plans, system/UAT test scripts, and test procedures.Strong verbal and written communication skills.Ability to work as a team player, lead a team, or accomplish tasks without supervision.Ability to work with remote teams and support several changes/projects simultaneously.Ability to provide validation guidance, timely reviews, and escalations to TQ management.","datePosted":"2026-09-11T13:00:22.438Z","dateModified":"2026-09-11T13:00:22.438Z","hiringOrganization":{"@type":"Organization","name":"Resource Logistics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"066f98caeb005c2da85c70f3"},"url":"https://jobsearcher.com/jobs/066f98caeb005c2da85c70f3"}}