{"schemaVersion":"jobsearcher.job.v1","id":"5e11c0c5cf0865c3a85e823b","url":"https://jobsearcher.com/jobs/5e11c0c5cf0865c3a85e823b","canonicalUrl":"https://jobsearcher.com/jobs/5e11c0c5cf0865c3a85e823b","title":"Computer Systems Validation Engineer","description":"The CSV Engineer is responsible for leading the end-to-end validation of computerized systems within the environment. This position will perform day-to-day tasks related to the design, creation, and execution of validation protocols, test scripts, change management, and end-user training activities.\n\nAdditionally, this position is expected to assist in creating new processes, ISO 13485:2016, GxP, and 21 CFR Part 11-related documentation to support and maintain the organization's computer systems validation efforts. This may include, but not be limited to, plans, URS documentation, assessments, and summary reports.\n\nSkills and Requirements\n\nLead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.\n\nCompile validation summary reports and secure required approvals for systems entering operational use.\n\nEnsure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs\n\nPerform risk assessments using approved methodology and apply a risk-based approach to all CSV activities.\n\nLead CSV response activities during system incidents or unplanned changes affecting validated environments.\n\nValidate and monitor cloud-based GxP applications in line with regulatory expectations.\n\nAuthor and review CSV SOPs, work instructions, and standard templates.\n\nServe as CSV subject matter expert during internal audits and external regulatory inspections for assigned systems.\n\nRequired Experience:\n\nMinimum 5 years of experience in CSV within a regulated environment (biotech, pharma, or medical devices)\n\nProven experience authoring and executing IQ/OQ/PQ protocols for a range of system types\n\nStrong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles\n\nDemonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously\n\nExperience supporting internal and external regulatory audits and inspections as a CSV subject matter expert\n\nExperience authoring and reviewing CSV SOPs, work instructions, and validation templates\n\nStrong interpersonal skills and an ability to work as an effective member of a team\n\nProven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.\n\n#J-18808-Ljbffr","company":"Bridgeview","rawCompany":"bridgeview","city":"Denver","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-11-03T04:11:35.872Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer Systems Validation Engineer","description":"The CSV Engineer is responsible for leading the end-to-end validation of computerized systems within the environment. This position will perform day-to-day tasks related to the design, creation, and execution of validation protocols, test scripts, change management, and end-user training activities.\n\nAdditionally, this position is expected to assist in creating new processes, ISO 13485:2016, GxP, and 21 CFR Part 11-related documentation to support and maintain the organization's computer systems validation efforts. This may include, but not be limited to, plans, URS documentation, assessments, and summary reports.\n\nSkills and Requirements\n\nLead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.\n\nCompile validation summary reports and secure required approvals for systems entering operational use.\n\nEnsure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs\n\nPerform risk assessments using approved methodology and apply a risk-based approach to all CSV activities.\n\nLead CSV response activities during system incidents or unplanned changes affecting validated environments.\n\nValidate and monitor cloud-based GxP applications in line with regulatory expectations.\n\nAuthor and review CSV SOPs, work instructions, and standard templates.\n\nServe as CSV subject matter expert during internal audits and external regulatory inspections for assigned systems.\n\nRequired Experience:\n\nMinimum 5 years of experience in CSV within a regulated environment (biotech, pharma, or medical devices)\n\nProven experience authoring and executing IQ/OQ/PQ protocols for a range of system types\n\nStrong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles\n\nDemonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously\n\nExperience supporting internal and external regulatory audits and inspections as a CSV subject matter expert\n\nExperience authoring and reviewing CSV SOPs, work instructions, and validation templates\n\nStrong interpersonal skills and an ability to work as an effective member of a team\n\nProven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.\n\n#J-18808-Ljbffr","datePosted":"2026-11-03T04:11:35.872Z","dateModified":"2026-11-03T04:11:35.872Z","hiringOrganization":{"@type":"Organization","name":"Bridgeview","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5e11c0c5cf0865c3a85e823b"},"url":"https://jobsearcher.com/jobs/5e11c0c5cf0865c3a85e823b"}}