{"schemaVersion":"jobsearcher.job.v1","id":"3c1df508ed656ca2f118a7a0","url":"https://jobsearcher.com/jobs/3c1df508ed656ca2f118a7a0","canonicalUrl":"https://jobsearcher.com/jobs/3c1df508ed656ca2f118a7a0","title":"Computer System Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\n\nWe are seeking a Computer System Validation Engineer to execute periodic reviews for approximately 42 computerized systems supporting QC and QA operations. The position will evaluate system lifecycle status, data integrity, changes, incidents, security controls, validation documentation, and continued fitness for intended use.\n\nComputer System Validation Engineer\n\nKey Responsibilities\n\nPlan and execute computerized-system periodic reviews according to approved schedules and procedures.\nReview system validation and lifecycle documentation, including:\nIntended use and current system configuration.\nValidation plans, requirements, specifications, testing, and reports.\nChange controls, incidents, deviations, CAPAs, and problem records.\nUser access, security roles, and periodic-access reviews.\nAudit trails and data-integrity controls.\nBackup, restoration, archival, and business-continuity controls.\nSoftware upgrades, patches, interfaces, and infrastructure changes.\nVendor support and system-obsolescence status.\nOpen validation actions and previous periodic-review commitments.\nAssess continued compliance with applicable cGMP, data-integrity, and electronic-record requirements.\nDocument validated-state conclusions, risks, recommendations, and required remediation.\nAuthor and route periodic-review reports, validation assessments, and supporting documents.\nSupport deviations, CAPAs, change controls, and investigations involving computerized systems.\nCollaborate with system owners, Quality, IT, Automation, laboratory personnel, and validation SMEs.\nProvide computerized-system documentation and SME support during audits and inspections.\nMaintain the computerized-system review schedule, trackers, metrics, and status reports.\n\nQualifications\n\nBachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline.\nFive or more years of computerized system validation experience in pharmaceutical or biotechnology operations.\nStrong knowledge of risk-based CSV, data integrity, ALCOA+ principles, 21 CFR Part 11, and applicable GAMP practices.\nExperience conducting computerized-system periodic reviews.\nExperience with laboratory or quality platforms such as LIMS, Maximo, TrackWise, PI Historian, RIM, QBMS, or comparable systems.\nExperience preparing audit-ready documentation in Kneat, CDOCs, or equivalent platforms.\n\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","company":"Validation","rawCompany":"validation","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-09-18T11:24:46.136Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\n\nWe are seeking a Computer System Validation Engineer to execute periodic reviews for approximately 42 computerized systems supporting QC and QA operations. The position will evaluate system lifecycle status, data integrity, changes, incidents, security controls, validation documentation, and continued fitness for intended use.\n\nComputer System Validation Engineer\n\nKey Responsibilities\n\nPlan and execute computerized-system periodic reviews according to approved schedules and procedures.\nReview system validation and lifecycle documentation, including:\nIntended use and current system configuration.\nValidation plans, requirements, specifications, testing, and reports.\nChange controls, incidents, deviations, CAPAs, and problem records.\nUser access, security roles, and periodic-access reviews.\nAudit trails and data-integrity controls.\nBackup, restoration, archival, and business-continuity controls.\nSoftware upgrades, patches, interfaces, and infrastructure changes.\nVendor support and system-obsolescence status.\nOpen validation actions and previous periodic-review commitments.\nAssess continued compliance with applicable cGMP, data-integrity, and electronic-record requirements.\nDocument validated-state conclusions, risks, recommendations, and required remediation.\nAuthor and route periodic-review reports, validation assessments, and supporting documents.\nSupport deviations, CAPAs, change controls, and investigations involving computerized systems.\nCollaborate with system owners, Quality, IT, Automation, laboratory personnel, and validation SMEs.\nProvide computerized-system documentation and SME support during audits and inspections.\nMaintain the computerized-system review schedule, trackers, metrics, and status reports.\n\nQualifications\n\nBachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline.\nFive or more years of computerized system validation experience in pharmaceutical or biotechnology operations.\nStrong knowledge of risk-based CSV, data integrity, ALCOA+ principles, 21 CFR Part 11, and applicable GAMP practices.\nExperience conducting computerized-system periodic reviews.\nExperience with laboratory or quality platforms such as LIMS, Maximo, TrackWise, PI Historian, RIM, QBMS, or comparable systems.\nExperience preparing audit-ready documentation in Kneat, CDOCs, or equivalent platforms.\n\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","datePosted":"2026-09-18T11:24:46.136Z","dateModified":"2026-09-18T11:24:46.136Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3c1df508ed656ca2f118a7a0"},"url":"https://jobsearcher.com/jobs/3c1df508ed656ca2f118a7a0"}}