{"schemaVersion":"jobsearcher.job.v1","id":"74369aac472e8b8d28b9dff9","url":"https://jobsearcher.com/jobs/74369aac472e8b8d28b9dff9","canonicalUrl":"https://jobsearcher.com/jobs/74369aac472e8b8d28b9dff9","title":"Computer Systems Validation Engineer","description":"Company Overview\nCAI is a 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.\n\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.\n\nKey Responsibilities\nDocumentation & Compliance\n\nAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)\n\nGenerate and execute test protocols and scripts\n\nEnsure adherence to 21 CFR Part 11 and data integrity principles\n\nReview and contribute to validation plans and risk assessments\n\nSystem & Industry Expertise\n\nSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systems\n\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\n\nApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)\n\nUtilize familiarity with S88/S95 batch control standards\n\nApply working knowledge of recipe authoring, batch recipe development, and S88‑based recipe structures across systems such as DeltaV and Rockwell\n\nClient Support & Technical Execution\n\nSupport client engagements with strong customer‑service orientation\n\nPerform system assessments and remediation related to data integrity\n\nCollaborate with client teams to ensure validation compliance and delivery\nQualifications and Experience\n\nBachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted\n\nMinimum of 3+ years of experience in computer systems validation\n\nExperience in biotech or pharmaceutical environments preferred over medical device\n\nIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)\n\nFamiliarity with S88/S95 batch control standards\n\nExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred\n\nExperience with multiple automation and manufacturing execution systems is highly desirable\n\nData integrity assessment/remediation experience is a plus\n\nOther Requirements\n\nExcellent oral and written communication skills in English\n\nAbility to travel domestically and internationally as required\n\nWillingness to work paid overtime when needed\n\nMust be authorized to work in the U.S. without current or future sponsorship\n\n#J-18808-Ljbffr","company":"Cagents","rawCompany":"cagents","city":"Indianapolis","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-06-26T04:51:40.350Z","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":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer Systems Validation Engineer","description":"Company Overview\nCAI is a 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.\n\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.\n\nKey Responsibilities\nDocumentation & Compliance\n\nAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)\n\nGenerate and execute test protocols and scripts\n\nEnsure adherence to 21 CFR Part 11 and data integrity principles\n\nReview and contribute to validation plans and risk assessments\n\nSystem & Industry Expertise\n\nSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systems\n\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\n\nApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)\n\nUtilize familiarity with S88/S95 batch control standards\n\nApply working knowledge of recipe authoring, batch recipe development, and S88‑based recipe structures across systems such as DeltaV and Rockwell\n\nClient Support & Technical Execution\n\nSupport client engagements with strong customer‑service orientation\n\nPerform system assessments and remediation related to data integrity\n\nCollaborate with client teams to ensure validation compliance and delivery\nQualifications and Experience\n\nBachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted\n\nMinimum of 3+ years of experience in computer systems validation\n\nExperience in biotech or pharmaceutical environments preferred over medical device\n\nIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)\n\nFamiliarity with S88/S95 batch control standards\n\nExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred\n\nExperience with multiple automation and manufacturing execution systems is highly desirable\n\nData integrity assessment/remediation experience is a plus\n\nOther Requirements\n\nExcellent oral and written communication skills in English\n\nAbility to travel domestically and internationally as required\n\nWillingness to work paid overtime when needed\n\nMust be authorized to work in the U.S. without current or future sponsorship\n\n#J-18808-Ljbffr","datePosted":"2026-06-26T04:51:40.350Z","dateModified":"2026-06-26T04:51:40.350Z","hiringOrganization":{"@type":"Organization","name":"Cagents","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Indianapolis","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"74369aac472e8b8d28b9dff9"},"url":"https://jobsearcher.com/jobs/74369aac472e8b8d28b9dff9"}}