{"schemaVersion":"jobsearcher.job.v1","id":"84bc7a4b5428d2084895f12c","url":"https://jobsearcher.com/jobs/84bc7a4b5428d2084895f12c","canonicalUrl":"https://jobsearcher.com/jobs/84bc7a4b5428d2084895f12c","title":"Computer System Validation Engineer","description":"Job Description:\nIn this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.\n\nResponsibilities:\n\nApply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.\nEnsure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.\nFacilitate risk assessments to identify validation deliverables and project requirements.\nCollaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.\nDevelop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.\nAnalyze validation data and troubleshoot issues in collaboration with technical teams.\nMaintain communication with stakeholders to address system needs, validation progress, and related concerns.\n\nRequirements:\n\nExperience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.\nHands-on experience in validating computerized systems.\nStrong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.\nAbility to work effectively in a dynamic, cross-functional team environment.\nProven expertise in applying data governance measures and creating impactful data visualizations.\nPreferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.\nBachelor's degree in computer science, Engineering, Biological Sciences, or a related field.","company":"Katalysthealthcares","rawCompany":"katalysthealthcares","city":"Phoenix","state":"AZ","isRemote":false,"isActive":false,"createdAt":"2026-08-27T12:47:41.986Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"334111","title":"Electronic Computer Manufacturing","slug":"electronic-computer-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Engineer","description":"Job Description:\nIn this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.\n\nResponsibilities:\n\nApply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.\nEnsure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.\nFacilitate risk assessments to identify validation deliverables and project requirements.\nCollaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.\nDevelop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.\nAnalyze validation data and troubleshoot issues in collaboration with technical teams.\nMaintain communication with stakeholders to address system needs, validation progress, and related concerns.\n\nRequirements:\n\nExperience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.\nHands-on experience in validating computerized systems.\nStrong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.\nAbility to work effectively in a dynamic, cross-functional team environment.\nProven expertise in applying data governance measures and creating impactful data visualizations.\nPreferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.\nBachelor's degree in computer science, Engineering, Biological Sciences, or a related field.","datePosted":"2026-08-27T12:47:41.986Z","dateModified":"2026-08-27T12:47:41.986Z","hiringOrganization":{"@type":"Organization","name":"Katalysthealthcares","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Phoenix","addressRegion":"AZ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"84bc7a4b5428d2084895f12c"},"url":"https://jobsearcher.com/jobs/84bc7a4b5428d2084895f12c"}}