{"schemaVersion":"jobsearcher.job.v1","id":"daf659f56e84e8b6977c1ebd","url":"https://jobsearcher.com/jobs/daf659f56e84e8b6977c1ebd","canonicalUrl":"https://jobsearcher.com/jobs/daf659f56e84e8b6977c1ebd","title":"Computer System Validation Engineer","description":"Job Summary:\nWe are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.\n\nThe CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.\n\nThe primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.\n\nRoles & Responsibilities:\n\nAuthor, review, and/or approve applicable CSV documentation.\n\nAssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.\n\nAssist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.\n\nSupport validation activities for Manufacturing Execution Systems (MES).\n\nDevelop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.\n\nEnsure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.\n\nSupport validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.\n\nUtilize IT service management platforms to support incident, problem, and change management activities.\n\nWork with Business Quality Management Systems and related validation processes.\n\nEducation & Experience:\n\nBachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.\n\nMinimum 4+ years of direct experience in Computer System Validation (CSV).\n\nStrong knowledge of GAMP and risk-based validation approaches.\n\nGood understanding of electronic records and electronic signatures.\n\nStrong knowledge of Manufacturing Execution System (MES) validation.\n\nFamiliarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.\n\nStrong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.\n\nKnowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.\n\nExperience with IT service management platforms such as ServiceNow.\n\nExposure to Business Quality Management Systems such as Veeva.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Bothell","state":"WA","isRemote":false,"isActive":true,"createdAt":"2026-06-26T05:32:00.794Z","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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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":"Job Summary:\nWe are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.\n\nThe CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.\n\nThe primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.\n\nRoles & Responsibilities:\n\nAuthor, review, and/or approve applicable CSV documentation.\n\nAssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.\n\nAssist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.\n\nSupport validation activities for Manufacturing Execution Systems (MES).\n\nDevelop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.\n\nEnsure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.\n\nSupport validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.\n\nUtilize IT service management platforms to support incident, problem, and change management activities.\n\nWork with Business Quality Management Systems and related validation processes.\n\nEducation & Experience:\n\nBachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.\n\nMinimum 4+ years of direct experience in Computer System Validation (CSV).\n\nStrong knowledge of GAMP and risk-based validation approaches.\n\nGood understanding of electronic records and electronic signatures.\n\nStrong knowledge of Manufacturing Execution System (MES) validation.\n\nFamiliarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.\n\nStrong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.\n\nKnowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.\n\nExperience with IT service management platforms such as ServiceNow.\n\nExposure to Business Quality Management Systems such as Veeva.\n\n#J-18808-Ljbffr","datePosted":"2026-06-26T05:32:00.794Z","dateModified":"2026-06-26T05:32:00.794Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"daf659f56e84e8b6977c1ebd"},"url":"https://jobsearcher.com/jobs/daf659f56e84e8b6977c1ebd"}}