{"schemaVersion":"jobsearcher.job.v1","id":"6826f3313df040baa71b749d","url":"https://jobsearcher.com/jobs/6826f3313df040baa71b749d","canonicalUrl":"https://jobsearcher.com/jobs/6826f3313df040baa71b749d","title":"Computer System Validation Lead","description":"As a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications.\n\nResponsibilities:\nDefine overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with QA policies.\n\nAuthor key validation documents: Validation Plans, Validation Summary reports, Test Plans, etc.\n\nAdvise project and technology teams on validation and data integrity best practices and approaches.\n\nCollaborate with GCP QA on process definition and improvement, author and revise CSV related SOPs.\n\nCoordinate with external Vendors on Validation and general IT operations support tasks.\n\nCoordinate CSV activities (UAT, document reviews) for clinical digital projects.\n\nLiaise with GMP CSV team to harmonize and streamline validation practices.\n\nProvide training on validation process and templates.\n\nOversee CSV readiness for inspections and audits, support QA and business team during inspection activities.\n\nRequirements:\n10+ years of computerized system validation experience with a primary focus on GCP, GVP and GLP.\n\n5+ years of validation team leadership providing coaching and mentoring to CSV engineers/tech writers and coordinating validation efforts within larger projects.\n\nProven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure. Broad understanding of Technology implementation (SaaS) and Data migrations approaches.\n\nWorking knowledge of CSV, data integrity and ICH guidance related to the use of computerized systems in clinical trials.\n\nSolid PM skills.\n\nExperience with Veeva platforms is a major plus.\n\nExtensive hands-on work with Validating GxP platforms such as RIM, QMS, SAS.\n\nHigh level experience with RIM processes.\n\nExperience supporting regulatory inspections related to computerized systems.\n\nExcellent communication skills.\n\nDemonstrated experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches.\n\nExperience with paperless validation preferred.\n\nBachelor’s degree in computer science, biotechnology, engineering, or equivalent.","company":"Arrayo","rawCompany":"arrayo","city":"East Boston","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-06T11:52:53.641Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541519","title":"Other Computer Related Services","slug":"other-computer-related-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Lead","description":"As a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications.\n\nResponsibilities:\nDefine overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with QA policies.\n\nAuthor key validation documents: Validation Plans, Validation Summary reports, Test Plans, etc.\n\nAdvise project and technology teams on validation and data integrity best practices and approaches.\n\nCollaborate with GCP QA on process definition and improvement, author and revise CSV related SOPs.\n\nCoordinate with external Vendors on Validation and general IT operations support tasks.\n\nCoordinate CSV activities (UAT, document reviews) for clinical digital projects.\n\nLiaise with GMP CSV team to harmonize and streamline validation practices.\n\nProvide training on validation process and templates.\n\nOversee CSV readiness for inspections and audits, support QA and business team during inspection activities.\n\nRequirements:\n10+ years of computerized system validation experience with a primary focus on GCP, GVP and GLP.\n\n5+ years of validation team leadership providing coaching and mentoring to CSV engineers/tech writers and coordinating validation efforts within larger projects.\n\nProven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure. Broad understanding of Technology implementation (SaaS) and Data migrations approaches.\n\nWorking knowledge of CSV, data integrity and ICH guidance related to the use of computerized systems in clinical trials.\n\nSolid PM skills.\n\nExperience with Veeva platforms is a major plus.\n\nExtensive hands-on work with Validating GxP platforms such as RIM, QMS, SAS.\n\nHigh level experience with RIM processes.\n\nExperience supporting regulatory inspections related to computerized systems.\n\nExcellent communication skills.\n\nDemonstrated experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches.\n\nExperience with paperless validation preferred.\n\nBachelor’s degree in computer science, biotechnology, engineering, or equivalent.","datePosted":"2026-08-06T11:52:53.641Z","dateModified":"2026-08-06T11:52:53.641Z","hiringOrganization":{"@type":"Organization","name":"Arrayo","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"East Boston","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6826f3313df040baa71b749d"},"url":"https://jobsearcher.com/jobs/6826f3313df040baa71b749d"}}