{"schemaVersion":"jobsearcher.job.v1","id":"3bd25029eddd243eb35339d1","url":"https://jobsearcher.com/jobs/3bd25029eddd243eb35339d1","canonicalUrl":"https://jobsearcher.com/jobs/3bd25029eddd243eb35339d1","title":"Computer Systems Validation Engineer","description":"Are You Ready?\r\nCAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.\r\nOur approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there.\r\nOur Foundational Principles\r\n\r\nWe act with integrity\r\nWe serve each other\r\nWe serve society\r\nWe work for our future\r\n\r\nWith employee ownership, one person's success is everyone's success. We work diligently to accomplish team goals and live our core values:\r\n\r\nTeam Before Self\r\nRespect for Others\r\nCan-Do Attitude\r\n\r\nKey Responsibilities\r\nDocumentation & Compliance\r\nAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)\r\nGenerate and execute test protocols and scripts\r\nEnsure adherence to 21 CFR Part 11 and data integrity principles\r\nReview and contribute to validation plans and risk assessments\r\nSystem & Industry Expertise\r\nSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systems\r\nEngage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware\r\nApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)\r\nUtilize familiarity with S88/S95 batch control standards\r\nApply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell\r\nClient Support & Technical Execution\r\nSupport client engagements with strong customer-service orientation\r\nPerform system assessments and remediation related to data integrity\r\nCollaborate with client teams to ensure validation compliance and delivery\r\nQualifications and Experience\r\nBachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted\r\nMinimum of 3+ years of experience in computer systems validation\r\nExperience in biotech or pharmaceutical environments preferred over medical device\r\nIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)\r\nFamiliarity with S88/S95 batch control standards\r\nExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred\r\nExperience with multiple automation and manufacturing execution systems is highly desirable\r\nData integrity assessment/remediation experience is a plus\r\nOther Requirements\r\n\r\nExcellent oral and written communication skills in English\r\nAbility to travel domestically and internationally as required\r\nWillingness to work paid overtime when needed\r\nMust be authorized to work in the U.S. without current or future sponsorship\r\n\r\nCritical Competencies\r\nInfluence Strategy\r\n\r\nPursues opportunities based on organizational fit and strategy\r\nIdentifies high-impact, innovative solutions\r\n\r\nSatisfy the Customer\r\n\r\nAnticipates and meets client needs\r\nDelivers high-quality solutions and maintains satisfaction\r\n\r\nPlan for Success\r\n\r\nAligns business goals with execution plans\r\nAllocates resources and builds risk mitigation strategies\r\n\r\nPursue Execution\r\n\r\nPrioritizes effectively and ensures accountability\r\nProactively addresses challenges\r\n\r\nTailor Communication\r\n\r\nCommunicates clearly and professionally\r\nAdapts style for technical and non-technical audiences\r\n\r\nBuild Partnerships\r\n\r\nBuilds cross-functional networks\r\nPromotes collaboration and stakeholder engagement\r\n\r\nInfluence Others\r\n\r\nGains support through sound reasoning\r\nPromotes innovation and value\r\n\r\nDevelop Self and Others\r\n\r\nDemonstrates integrity and commitment to growth\r\nBuilds effective relationships internally and externally\r\n\r\nLI-MV1\r\n$40 - $47.30 an hour\r\nAverage base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.\r\nCAI Benefits\r\n\r\nComprehensive Health Insurance coverage\r\n24 days of Paid Time Off\r\nESOP/401K - 15% Company Contribution (US Only)\r\nCompany paid Life Insurance\r\nCompany paid Long Term Disability\r\n\r\nWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.\r\nThis job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).\r\nWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","company":"Commissioning Agents","rawCompany":"commissioning agents","city":"Raleigh","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-05-21T06:25:55.943Z","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":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer Systems Validation Engineer","description":"Are You Ready?\r\nCAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.\r\nOur approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there.\r\nOur Foundational Principles\r\n\r\nWe act with integrity\r\nWe serve each other\r\nWe serve society\r\nWe work for our future\r\n\r\nWith employee ownership, one person's success is everyone's success. We work diligently to accomplish team goals and live our core values:\r\n\r\nTeam Before Self\r\nRespect for Others\r\nCan-Do Attitude\r\n\r\nKey Responsibilities\r\nDocumentation & Compliance\r\nAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)\r\nGenerate and execute test protocols and scripts\r\nEnsure adherence to 21 CFR Part 11 and data integrity principles\r\nReview and contribute to validation plans and risk assessments\r\nSystem & Industry Expertise\r\nSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systems\r\nEngage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware\r\nApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)\r\nUtilize familiarity with S88/S95 batch control standards\r\nApply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell\r\nClient Support & Technical Execution\r\nSupport client engagements with strong customer-service orientation\r\nPerform system assessments and remediation related to data integrity\r\nCollaborate with client teams to ensure validation compliance and delivery\r\nQualifications and Experience\r\nBachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted\r\nMinimum of 3+ years of experience in computer systems validation\r\nExperience in biotech or pharmaceutical environments preferred over medical device\r\nIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)\r\nFamiliarity with S88/S95 batch control standards\r\nExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred\r\nExperience with multiple automation and manufacturing execution systems is highly desirable\r\nData integrity assessment/remediation experience is a plus\r\nOther Requirements\r\n\r\nExcellent oral and written communication skills in English\r\nAbility to travel domestically and internationally as required\r\nWillingness to work paid overtime when needed\r\nMust be authorized to work in the U.S. without current or future sponsorship\r\n\r\nCritical Competencies\r\nInfluence Strategy\r\n\r\nPursues opportunities based on organizational fit and strategy\r\nIdentifies high-impact, innovative solutions\r\n\r\nSatisfy the Customer\r\n\r\nAnticipates and meets client needs\r\nDelivers high-quality solutions and maintains satisfaction\r\n\r\nPlan for Success\r\n\r\nAligns business goals with execution plans\r\nAllocates resources and builds risk mitigation strategies\r\n\r\nPursue Execution\r\n\r\nPrioritizes effectively and ensures accountability\r\nProactively addresses challenges\r\n\r\nTailor Communication\r\n\r\nCommunicates clearly and professionally\r\nAdapts style for technical and non-technical audiences\r\n\r\nBuild Partnerships\r\n\r\nBuilds cross-functional networks\r\nPromotes collaboration and stakeholder engagement\r\n\r\nInfluence Others\r\n\r\nGains support through sound reasoning\r\nPromotes innovation and value\r\n\r\nDevelop Self and Others\r\n\r\nDemonstrates integrity and commitment to growth\r\nBuilds effective relationships internally and externally\r\n\r\nLI-MV1\r\n$40 - $47.30 an hour\r\nAverage base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.\r\nCAI Benefits\r\n\r\nComprehensive Health Insurance coverage\r\n24 days of Paid Time Off\r\nESOP/401K - 15% Company Contribution (US Only)\r\nCompany paid Life Insurance\r\nCompany paid Long Term Disability\r\n\r\nWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.\r\nThis job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).\r\nWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","datePosted":"2026-05-21T06:25:55.943Z","dateModified":"2026-05-21T06:25:55.943Z","hiringOrganization":{"@type":"Organization","name":"Commissioning Agents","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raleigh","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3bd25029eddd243eb35339d1"},"url":"https://jobsearcher.com/jobs/3bd25029eddd243eb35339d1"}}