{"schemaVersion":"jobsearcher.job.v1","id":"34ca59a9ab1417432fdb01ac","url":"https://jobsearcher.com/jobs/34ca59a9ab1417432fdb01ac","canonicalUrl":"https://jobsearcher.com/jobs/34ca59a9ab1417432fdb01ac","title":"Computerized System Validation (CSV) Specialist","description":"Computerized System Validation (CSV) Specialist — Contract (Remote)\nJob Type: Contract — 12-month engagement, with strong possibility of extension\nLocation: Remote\nStart Date: Immediate availability strongly preferred\nAbout DoubleBridge Technologies\nDoubleBridge Technologies is a global software and consulting company serving pharmaceutical, biotechnology, and life sciences organizations worldwide. Our expertise spans Computerized System Validation (CSV), Quality Engineering (QE), Regulatory Operations, eCTD Publishing, AI-enabled validation, and enterprise software solutions. We support some of the world's leading pharmaceutical companies by providing experienced professionals who deliver high-quality software validation, testing, and regulated system implementation services.\nPosition Summary\nWe are seeking an experienced Computerized System Validation (CSV) Specialist to support validation activities for a global pharmaceutical client operating within regulated environments. This is a hands-on validation delivery role responsible for executing and coordinating computerized system validation activities throughout the Software Development Lifecycle (SDLC) and Validation Lifecycle.\nThis is a 12-month contract position, with the opportunity to extend based on performance and client needs. Candidates who can start immediately or on short notice will be prioritized.\nThe successful candidate will work as part of the client's validation organization, collaborating closely with business users, Quality Assurance, Development, Testing, Infrastructure, and Project Management teams to ensure systems are validated, compliant, and ready for production deployment.\nKey Responsibilities\nExecute computerized system validation (CSV) activities throughout the system validation lifecycle\nPrepare, review, and maintain validation documentation, including Validation Plans, Requirements Traceability Matrix (RTM), Functional and Design Review documentation, Test Protocols (IQ/OQ/PQ/UAT), Validation Reports, and Validation Summary Reports\nCoordinate validation activities across Business, Development, Testing, Infrastructure, and Quality teams\nSupport software validation planning, verification, deployment readiness, operational support, and business continuity activities\nParticipate in requirements reviews to ensure completeness, traceability, and testability\nSupport risk assessments and validation planning using risk-based validation principles\nCoordinate User Acceptance Testing (UAT), defect management, deviation tracking, and issue resolution\nEnsure validation deliverables comply with client quality procedures and regulatory expectations\nSupport change control, system enhancements, periodic reviews, and validation maintenance activities\nMaintain high-quality documentation suitable for regulatory inspection and audit readiness\nRequired Qualifications\nBachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline\nMinimum 5 years of experience in Computerized System Validation (CSV), Software Validation, Software Quality Assurance, or Validation Delivery within pharmaceutical, biotechnology, medical device, or other regulated industries\nAt least mid-level knowledge of Computerized System Validation, Quality Assurance, and regulated environments\nPractical experience with Software Development Lifecycle (SDLC), System Lifecycle, and Validation Lifecycle methodologies\nWorking knowledge of Infrastructure Lifecycle\nSolid understanding of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11\nStrong grasp of Data Integrity principles and Risk Management methodologies\nExperience preparing, reviewing, or coordinating validation documentation for GxP-regulated computerized systems\nStrong understanding of software testing methodologies and User Acceptance Testing (UAT)\nAbility to manage multiple priorities in a fast-paced project environment\nPreferred Qualifications\nExperience in one or more of the following is an advantage:\nLaboratory, Clinical, Regulatory, or Manufacturing systems\nDocument Management Systems (DMS) or Trial Master File (TMF)\nCloud-based GxP applications\nValidation automation and Agile software delivery environments\nTools such as Jira, HP ALM / Quality Center, Azure DevOps, qTest, SharePoint; basic SQL knowledge a plus\nEnglish Language Requirement (Mandatory)\nExcellent English communication skills are required. This position directly supports global pharmaceutical clients. Candidates must be able to communicate fluently and professionally in English, both verbally and in writing, including participating in daily meetings with international stakeholders, leading discussions with business and technical teams, and writing professional validation documentation. Business-level spoken and written English is mandatory.\nWhat We Offer\n12-month contract with strong potential for extension\nFully remote work with a global pharmaceutical client\nOpportunity to work on regulated, high-impact validation projects\nHow to Apply\nPlease send your resume/CV to hr@doublebridge.com.\nCandidates who are available to start immediately or on short notice are strongly encouraged to apply.\nPay: $81,619.46 - $98,294.41 per year\nWork Location: Remote","company":"Doublebridge Technologies","rawCompany":"doublebridge technologies","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-04T19:50:12.260Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"}],"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":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computerized System Validation (CSV) Specialist","description":"Computerized System Validation (CSV) Specialist — Contract (Remote)\nJob Type: Contract — 12-month engagement, with strong possibility of extension\nLocation: Remote\nStart Date: Immediate availability strongly preferred\nAbout DoubleBridge Technologies\nDoubleBridge Technologies is a global software and consulting company serving pharmaceutical, biotechnology, and life sciences organizations worldwide. Our expertise spans Computerized System Validation (CSV), Quality Engineering (QE), Regulatory Operations, eCTD Publishing, AI-enabled validation, and enterprise software solutions. We support some of the world's leading pharmaceutical companies by providing experienced professionals who deliver high-quality software validation, testing, and regulated system implementation services.\nPosition Summary\nWe are seeking an experienced Computerized System Validation (CSV) Specialist to support validation activities for a global pharmaceutical client operating within regulated environments. This is a hands-on validation delivery role responsible for executing and coordinating computerized system validation activities throughout the Software Development Lifecycle (SDLC) and Validation Lifecycle.\nThis is a 12-month contract position, with the opportunity to extend based on performance and client needs. Candidates who can start immediately or on short notice will be prioritized.\nThe successful candidate will work as part of the client's validation organization, collaborating closely with business users, Quality Assurance, Development, Testing, Infrastructure, and Project Management teams to ensure systems are validated, compliant, and ready for production deployment.\nKey Responsibilities\nExecute computerized system validation (CSV) activities throughout the system validation lifecycle\nPrepare, review, and maintain validation documentation, including Validation Plans, Requirements Traceability Matrix (RTM), Functional and Design Review documentation, Test Protocols (IQ/OQ/PQ/UAT), Validation Reports, and Validation Summary Reports\nCoordinate validation activities across Business, Development, Testing, Infrastructure, and Quality teams\nSupport software validation planning, verification, deployment readiness, operational support, and business continuity activities\nParticipate in requirements reviews to ensure completeness, traceability, and testability\nSupport risk assessments and validation planning using risk-based validation principles\nCoordinate User Acceptance Testing (UAT), defect management, deviation tracking, and issue resolution\nEnsure validation deliverables comply with client quality procedures and regulatory expectations\nSupport change control, system enhancements, periodic reviews, and validation maintenance activities\nMaintain high-quality documentation suitable for regulatory inspection and audit readiness\nRequired Qualifications\nBachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline\nMinimum 5 years of experience in Computerized System Validation (CSV), Software Validation, Software Quality Assurance, or Validation Delivery within pharmaceutical, biotechnology, medical device, or other regulated industries\nAt least mid-level knowledge of Computerized System Validation, Quality Assurance, and regulated environments\nPractical experience with Software Development Lifecycle (SDLC), System Lifecycle, and Validation Lifecycle methodologies\nWorking knowledge of Infrastructure Lifecycle\nSolid understanding of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11\nStrong grasp of Data Integrity principles and Risk Management methodologies\nExperience preparing, reviewing, or coordinating validation documentation for GxP-regulated computerized systems\nStrong understanding of software testing methodologies and User Acceptance Testing (UAT)\nAbility to manage multiple priorities in a fast-paced project environment\nPreferred Qualifications\nExperience in one or more of the following is an advantage:\nLaboratory, Clinical, Regulatory, or Manufacturing systems\nDocument Management Systems (DMS) or Trial Master File (TMF)\nCloud-based GxP applications\nValidation automation and Agile software delivery environments\nTools such as Jira, HP ALM / Quality Center, Azure DevOps, qTest, SharePoint; basic SQL knowledge a plus\nEnglish Language Requirement (Mandatory)\nExcellent English communication skills are required. This position directly supports global pharmaceutical clients. Candidates must be able to communicate fluently and professionally in English, both verbally and in writing, including participating in daily meetings with international stakeholders, leading discussions with business and technical teams, and writing professional validation documentation. Business-level spoken and written English is mandatory.\nWhat We Offer\n12-month contract with strong potential for extension\nFully remote work with a global pharmaceutical client\nOpportunity to work on regulated, high-impact validation projects\nHow to Apply\nPlease send your resume/CV to hr@doublebridge.com.\nCandidates who are available to start immediately or on short notice are strongly encouraged to apply.\nPay: $81,619.46 - $98,294.41 per year\nWork Location: Remote","datePosted":"2026-08-04T19:50:12.260Z","dateModified":"2026-08-04T19:50:12.260Z","hiringOrganization":{"@type":"Organization","name":"Doublebridge Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"34ca59a9ab1417432fdb01ac"},"url":"https://jobsearcher.com/jobs/34ca59a9ab1417432fdb01ac"}}