{"schemaVersion":"jobsearcher.job.v1","id":"ec4a4bf52febba2c1c793cb5","url":"https://jobsearcher.com/jobs/ec4a4bf52febba2c1c793cb5","canonicalUrl":"https://jobsearcher.com/jobs/ec4a4bf52febba2c1c793cb5","title":"Computer system Validation tester","description":"Computer System Validation Specialist• 8+ years of experience in CSV Implementation • Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan • Experience in CSV for Lab systems especially LabVantage version 8, Serialization, trackwise systems • CSV/21CFRPart11/GxP/ • Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc. • Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan • Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation • Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV • Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures. • Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel • Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems • Responsible for review & verification of Corrective Action Plan for audits • Perform periodic review/monitoring of computer systems implemented • Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process Key Skills: Computer System Validation for Lab systems","company":"Clifyx","rawCompany":"clifyx","city":"Somerset","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-07-24T00:32:22.149Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer system Validation tester","description":"Computer System Validation Specialist• 8+ years of experience in CSV Implementation • Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan • Experience in CSV for Lab systems especially LabVantage version 8, Serialization, trackwise systems • CSV/21CFRPart11/GxP/ • Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc. • Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan • Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation • Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV • Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures. • Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel • Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems • Responsible for review & verification of Corrective Action Plan for audits • Perform periodic review/monitoring of computer systems implemented • Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process Key Skills: Computer System Validation for Lab systems","datePosted":"2026-07-24T00:32:22.149Z","dateModified":"2026-07-24T00:32:22.149Z","hiringOrganization":{"@type":"Organization","name":"Clifyx","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerset","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ec4a4bf52febba2c1c793cb5"},"url":"https://jobsearcher.com/jobs/ec4a4bf52febba2c1c793cb5"}}