{"schemaVersion":"jobsearcher.job.v1","id":"ad832e05b9eff7540a585888","url":"https://jobsearcher.com/jobs/ad832e05b9eff7540a585888","canonicalUrl":"https://jobsearcher.com/jobs/ad832e05b9eff7540a585888","title":"Computer System Validation Engineer","description":"KEY RESPONSIBILITIES\n\nFamiliarity with Manufacturing Execution Systems (MES)\n\nProtocol drafting and execution, good communication\n\nRequired to be onsite throughout UAT execution\n\nPURPOSE AND SCOPE OF POSITION\nThe Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant Client procedures and regulations.\n\nDUTIES AND 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 to develop requirements and specifications for computerized systems used in GxP operations\n\nOther related duties as assigned\n\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities\n\nAbility to effectively communicate with both technical and non-technical team members.\n\nStrong interpersonal skills, especially regarding team work, client focus, verbal and written communication\n\nKnowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.\n\nKnowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.\n\nKnowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).\n\nKnowledge and exposure to Business Quality Management Systems (i.e. Veeva).\n\nStrong technical and problem-solving skills and the ability to work independently.\n\nDemonstrated success working in a high-performing, business results-driven environment.\n\nUnderstanding of computer system validation.\n\nFamiliarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).\n\nUnderstanding of computer system validation (CSV).\n\nEDUCATION AND EXPERIENCE\n\nBachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures\n\nStrong knowledge on Manufacturing Execution System (MES) validation.\n\nStrong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures\n\nStrong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)\n\n#J-18808-Ljbffr","company":"Artechllccom","rawCompany":"artechllccom","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-07-16T04:03:38.845Z","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":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Engineer","description":"KEY RESPONSIBILITIES\n\nFamiliarity with Manufacturing Execution Systems (MES)\n\nProtocol drafting and execution, good communication\n\nRequired to be onsite throughout UAT execution\n\nPURPOSE AND SCOPE OF POSITION\nThe Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant Client procedures and regulations.\n\nDUTIES AND 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 to develop requirements and specifications for computerized systems used in GxP operations\n\nOther related duties as assigned\n\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities\n\nAbility to effectively communicate with both technical and non-technical team members.\n\nStrong interpersonal skills, especially regarding team work, client focus, verbal and written communication\n\nKnowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.\n\nKnowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.\n\nKnowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).\n\nKnowledge and exposure to Business Quality Management Systems (i.e. Veeva).\n\nStrong technical and problem-solving skills and the ability to work independently.\n\nDemonstrated success working in a high-performing, business results-driven environment.\n\nUnderstanding of computer system validation.\n\nFamiliarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).\n\nUnderstanding of computer system validation (CSV).\n\nEDUCATION AND EXPERIENCE\n\nBachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures\n\nStrong knowledge on Manufacturing Execution System (MES) validation.\n\nStrong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures\n\nStrong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T04:03:38.845Z","dateModified":"2026-07-16T04:03:38.845Z","hiringOrganization":{"@type":"Organization","name":"Artechllccom","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ad832e05b9eff7540a585888"},"url":"https://jobsearcher.com/jobs/ad832e05b9eff7540a585888"}}