{"schemaVersion":"jobsearcher.job.v1","id":"11830e5779aff40fd02f062f","url":"https://jobsearcher.com/jobs/11830e5779aff40fd02f062f","canonicalUrl":"https://jobsearcher.com/jobs/11830e5779aff40fd02f062f","title":"CSV Consultant","description":"Project Overview:\nModerna is seeking a Computer System Validation (CSV) Consultant to support the validation of bioinformatics software, data analysis platforms, and scientific algorithms used in a GMP-regulated environment. This individual will ensure computerized systems are implemented and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 while partnering with Bioinformatics, IT, Quality, and Laboratory teams.\nKey Responsibilities:\n\nPerform validation of bioinformatics software and data analysis systems.\nDevelop and execute validation documentation including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Summary Reports.\nValidate scientific algorithms and automated data processing workflows to ensure accuracy and reproducibility.\nSupport implementation and upgrades of laboratory software, genomic analysis platforms, and cloud-based applications.\nCollaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.\nReview software changes, perform impact assessments, and support change control activities.\nEnsure compliance with GAMP 5, 21 CFR Part 11, and internal CSV standards.\n\nPreferred Experience:\n\nComputer System Validation (CSV) within the pharmaceutical or biotechnology industry.\nExperience validating laboratory or scientific software in a GxP environment.\nFamiliarity with bioinformatics, genomics, Next Generation Sequencing (NGS), or computational biology workflows.\nUnderstanding of scientific algorithms, automated data analysis, or Python/R-based pipelines.\nKnowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.\nExperience working with Quality, IT, Bioinformatics, and Laboratory teams.","company":"Ar Validation Services","rawCompany":"ar validation services","city":"Silver Spring","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-08-04T22:49:19.690Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"19-1029.01","title":"Bioinformatics Scientists","slug":"bioinformatics-scientists"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Consultant","description":"Project Overview:\nModerna is seeking a Computer System Validation (CSV) Consultant to support the validation of bioinformatics software, data analysis platforms, and scientific algorithms used in a GMP-regulated environment. This individual will ensure computerized systems are implemented and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 while partnering with Bioinformatics, IT, Quality, and Laboratory teams.\nKey Responsibilities:\n\nPerform validation of bioinformatics software and data analysis systems.\nDevelop and execute validation documentation including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Summary Reports.\nValidate scientific algorithms and automated data processing workflows to ensure accuracy and reproducibility.\nSupport implementation and upgrades of laboratory software, genomic analysis platforms, and cloud-based applications.\nCollaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.\nReview software changes, perform impact assessments, and support change control activities.\nEnsure compliance with GAMP 5, 21 CFR Part 11, and internal CSV standards.\n\nPreferred Experience:\n\nComputer System Validation (CSV) within the pharmaceutical or biotechnology industry.\nExperience validating laboratory or scientific software in a GxP environment.\nFamiliarity with bioinformatics, genomics, Next Generation Sequencing (NGS), or computational biology workflows.\nUnderstanding of scientific algorithms, automated data analysis, or Python/R-based pipelines.\nKnowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.\nExperience working with Quality, IT, Bioinformatics, and Laboratory teams.","datePosted":"2026-08-04T22:49:19.690Z","dateModified":"2026-08-04T22:49:19.690Z","hiringOrganization":{"@type":"Organization","name":"Ar Validation Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Silver Spring","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"11830e5779aff40fd02f062f"},"url":"https://jobsearcher.com/jobs/11830e5779aff40fd02f062f"}}