{"schemaVersion":"jobsearcher.job.v1","id":"db30f918c1dbd23745df6d72","url":"https://jobsearcher.com/jobs/db30f918c1dbd23745df6d72","canonicalUrl":"https://jobsearcher.com/jobs/db30f918c1dbd23745df6d72","title":"Computer System Validation (CSV) Engineer","description":"Job Title: Computer System Validation (CSV) EngineerLocation: Portsmouth, NH (Onsite)Job SummaryOur pharmaceutical client is seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated computerized systems. This role will serve as the CSV subject matter expert for validation projects, ensuring systems remain compliant with FDA regulations, GAMP 5 principles, and internal quality standards. The ideal candidate will have hands-on experience with manufacturing automation systems such as DeltaV and Syncade, along with strong knowledge of quality systems and validation lifecycle documentation.Key ResponsibilitiesServe as the QA/CSV representative on small and large-scale validation projects.Lead Computer System Validation (CSV) activities for GMP-regulated computerized systems from planning through execution.Perform risk assessments for new and modified computerized systems to ensure regulatory compliance.Review and approve change controls, deviations, CAPAs, and validation documentation.Develop, execute, and review validation protocols (IQ, OQ, PQ) and test scripts.Lead CSV activities for DeltaV and Syncade systems, including qualification and ongoing validation maintenance.Maintain the validated state of computerized systems through periodic reviews and lifecycle management.Review and update CSV-related SOPs and validation procedures.Review engineering documentation, including P&IDs, specifications, SOPs, design documents, and technical submittals.Support internal audits and regulatory inspections by providing CSV documentation and compliance expertise.Mentor and provide technical guidance to junior CSV team members.Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and IT teams to ensure project success.Required QualificationsBachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.5+ years of Computer System Validation (CSV) experience in a GMP-regulated pharmaceutical or biotechnology environment.Strong knowledge of FDA 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+), and GMP regulations.Experience supporting Quality Management System (QMS) processes, including Change Controls, Deviations, and CAPAs.Hands-on experience validating manufacturing systems such as DeltaV and Syncade.Experience authoring and executing IQ/OQ/PQ protocols, risk assessments, validation plans, and validation reports.Ability to review engineering documentation and collaborate across cross-functional teams.Strong communication, documentation, and problem-solving skills","company":"United Pharma Technologies","rawCompany":"united pharma technologies","city":"Rockingham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-08-07T08:58:58.082Z","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":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation (CSV) Engineer","description":"Job Title: Computer System Validation (CSV) EngineerLocation: Portsmouth, NH (Onsite)Job SummaryOur pharmaceutical client is seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated computerized systems. This role will serve as the CSV subject matter expert for validation projects, ensuring systems remain compliant with FDA regulations, GAMP 5 principles, and internal quality standards. The ideal candidate will have hands-on experience with manufacturing automation systems such as DeltaV and Syncade, along with strong knowledge of quality systems and validation lifecycle documentation.Key ResponsibilitiesServe as the QA/CSV representative on small and large-scale validation projects.Lead Computer System Validation (CSV) activities for GMP-regulated computerized systems from planning through execution.Perform risk assessments for new and modified computerized systems to ensure regulatory compliance.Review and approve change controls, deviations, CAPAs, and validation documentation.Develop, execute, and review validation protocols (IQ, OQ, PQ) and test scripts.Lead CSV activities for DeltaV and Syncade systems, including qualification and ongoing validation maintenance.Maintain the validated state of computerized systems through periodic reviews and lifecycle management.Review and update CSV-related SOPs and validation procedures.Review engineering documentation, including P&IDs, specifications, SOPs, design documents, and technical submittals.Support internal audits and regulatory inspections by providing CSV documentation and compliance expertise.Mentor and provide technical guidance to junior CSV team members.Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and IT teams to ensure project success.Required QualificationsBachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.5+ years of Computer System Validation (CSV) experience in a GMP-regulated pharmaceutical or biotechnology environment.Strong knowledge of FDA 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+), and GMP regulations.Experience supporting Quality Management System (QMS) processes, including Change Controls, Deviations, and CAPAs.Hands-on experience validating manufacturing systems such as DeltaV and Syncade.Experience authoring and executing IQ/OQ/PQ protocols, risk assessments, validation plans, and validation reports.Ability to review engineering documentation and collaborate across cross-functional teams.Strong communication, documentation, and problem-solving skills","datePosted":"2026-08-07T08:58:58.082Z","dateModified":"2026-08-07T08:58:58.082Z","hiringOrganization":{"@type":"Organization","name":"United Pharma Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Rockingham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"db30f918c1dbd23745df6d72"},"url":"https://jobsearcher.com/jobs/db30f918c1dbd23745df6d72"}}