{"schemaVersion":"jobsearcher.job.v1","id":"5b3d503527bc912e089c14d1","url":"https://jobsearcher.com/jobs/5b3d503527bc912e089c14d1","canonicalUrl":"https://jobsearcher.com/jobs/5b3d503527bc912e089c14d1","title":"CSV Engineer","description":"Job Summary:\nThe CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana.\n\nRoles & Responsibilities:\n\nExecute and manage computer system validation (CSV) activities in compliance with GAMP 5 and GMP regulations\n\nDevelop and review validation documentation including Validation Plans, URS (User Requirement Specifications), FS (Functional Specifications), DS (Design Specifications), and protocols (IQ/OQ/PQ)\n\nPerform and oversee execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)\n\nEnsure compliance with 21 CFR Part 11 requirements, including electronic records, audit trails, and data integrity\n\nWork with automation and control systems such as DeltaV, PI Historian, Rockwell PLC, HMI, or similar platforms\n\nApply risk-based validation approaches and V-model lifecycle principles\n\nMaintain and manage validation documentation such as RTMs (Requirement Traceability Matrices), validation summary reports, and SOPs\n\nCollaborate with cross-functional teams including Automation, Quality Assurance, and IT\n\nSupport internal and external audits by providing validation documentation and compliance evidence\n\nEducation & Experience:\n\nBachelor's degree in Engineering, Computer Science, Life Sciences, or a related field\n\nMinimum of 7+ years of experience in Computer System Validation within a pharmaceutical or GMP-regulated environment\n\nStrong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches\n\nHands-on experience with automation and control systems (e.g., DeltaV, PI Historian, Rockwell PLC, HMI)\n\nProven experience supporting 21 CFR Part 11 compliance and data integrity requirements\n\nExcellent documentation, communication, and stakeholder management skills\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Bloomfield","state":"IN","isRemote":false,"isActive":true,"createdAt":"2026-06-17T04:17:15.116Z","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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-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":"CSV Engineer","description":"Job Summary:\nThe CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana.\n\nRoles & Responsibilities:\n\nExecute and manage computer system validation (CSV) activities in compliance with GAMP 5 and GMP regulations\n\nDevelop and review validation documentation including Validation Plans, URS (User Requirement Specifications), FS (Functional Specifications), DS (Design Specifications), and protocols (IQ/OQ/PQ)\n\nPerform and oversee execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)\n\nEnsure compliance with 21 CFR Part 11 requirements, including electronic records, audit trails, and data integrity\n\nWork with automation and control systems such as DeltaV, PI Historian, Rockwell PLC, HMI, or similar platforms\n\nApply risk-based validation approaches and V-model lifecycle principles\n\nMaintain and manage validation documentation such as RTMs (Requirement Traceability Matrices), validation summary reports, and SOPs\n\nCollaborate with cross-functional teams including Automation, Quality Assurance, and IT\n\nSupport internal and external audits by providing validation documentation and compliance evidence\n\nEducation & Experience:\n\nBachelor's degree in Engineering, Computer Science, Life Sciences, or a related field\n\nMinimum of 7+ years of experience in Computer System Validation within a pharmaceutical or GMP-regulated environment\n\nStrong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches\n\nHands-on experience with automation and control systems (e.g., DeltaV, PI Historian, Rockwell PLC, HMI)\n\nProven experience supporting 21 CFR Part 11 compliance and data integrity requirements\n\nExcellent documentation, communication, and stakeholder management skills\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:17:15.116Z","dateModified":"2026-06-17T04:17:15.116Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomfield","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5b3d503527bc912e089c14d1"},"url":"https://jobsearcher.com/jobs/5b3d503527bc912e089c14d1"}}