{"schemaVersion":"jobsearcher.job.v1","id":"2a32c8c253f97c08b90dd2cc","url":"https://jobsearcher.com/jobs/2a32c8c253f97c08b90dd2cc","canonicalUrl":"https://jobsearcher.com/jobs/2a32c8c253f97c08b90dd2cc","title":"CSV Analyst","description":"Computer System Validation (CSV) Specialist / Validation Engineer Overview We are seeking an experienced Computer System Validation (CSV) Specialist to support validation activities for computerized manufacturing systems and laboratory instruments within a regulated environment. This role is responsible for leading validation efforts end-to-end, ensuring systems meet regulatory, data integrity, security, and business requirements in accordance with GxP and 21 CFR Part 11 expectations. Key Responsibilities - Lead validation projects for computerized manufacturing systems and laboratory instruments from planning through execution and approval. - Collaborate with business process owners, IT, software development teams, and Quality representatives. - Assess computerized systems for intended use, data integrity, security, and compliance impact. - Author validation documentation including Validation Plans, Requirements Specifications, Design Specifications, Test Protocols, and Validation Summary Reports. - Develop Security Plans, Business Continuity Plans, and supporting procedures. - Execute and document validation testing activities. - Investigate and resolve deviations, test failures, and validation issues. - Ensure compliance with corporate policies, site procedures, GxP requirements, and 21 CFR Part 11. Required Qualifications - Experience performing Computer System Validation in regulated environments. - Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles. - Proven experience authoring and executing validation documentation. - Strong collaboration and communication skills. Preferred Qualifications - Experience with manufacturing or laboratory systems. - Familiarity with SDLC and change management. - Experience supporting audits or inspections.","company":"Brooksource","rawCompany":"brooksource","city":"Indianapolis","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-05-03T02:52:04.275Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"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":"CSV Analyst","description":"Computer System Validation (CSV) Specialist / Validation Engineer Overview We are seeking an experienced Computer System Validation (CSV) Specialist to support validation activities for computerized manufacturing systems and laboratory instruments within a regulated environment. This role is responsible for leading validation efforts end-to-end, ensuring systems meet regulatory, data integrity, security, and business requirements in accordance with GxP and 21 CFR Part 11 expectations. Key Responsibilities - Lead validation projects for computerized manufacturing systems and laboratory instruments from planning through execution and approval. - Collaborate with business process owners, IT, software development teams, and Quality representatives. - Assess computerized systems for intended use, data integrity, security, and compliance impact. - Author validation documentation including Validation Plans, Requirements Specifications, Design Specifications, Test Protocols, and Validation Summary Reports. - Develop Security Plans, Business Continuity Plans, and supporting procedures. - Execute and document validation testing activities. - Investigate and resolve deviations, test failures, and validation issues. - Ensure compliance with corporate policies, site procedures, GxP requirements, and 21 CFR Part 11. Required Qualifications - Experience performing Computer System Validation in regulated environments. - Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles. - Proven experience authoring and executing validation documentation. - Strong collaboration and communication skills. Preferred Qualifications - Experience with manufacturing or laboratory systems. - Familiarity with SDLC and change management. - Experience supporting audits or inspections.","datePosted":"2026-05-03T02:52:04.275Z","dateModified":"2026-05-03T02:52:04.275Z","hiringOrganization":{"@type":"Organization","name":"Brooksource","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Indianapolis","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2a32c8c253f97c08b90dd2cc"},"url":"https://jobsearcher.com/jobs/2a32c8c253f97c08b90dd2cc"}}