{"schemaVersion":"jobsearcher.job.v1","id":"cbccd02689426f1485cefd39","url":"https://jobsearcher.com/jobs/cbccd02689426f1485cefd39","canonicalUrl":"https://jobsearcher.com/jobs/cbccd02689426f1485cefd39","title":"Instrument Software validation Engineer - W2 Only","description":"Job Title: Instrument Software validation EngineerLocation- Remote W2 PositionNameCoreLIMSGAMPGxP AssessmentMedical Devices regulationsMedical device developmentSoftware validationCSVKey ResponsibilitiesDocument and validate software installed on lab instruments per EMA regulatory standards.Validate Instruments and Instrument IntegrationMigrate instrument software management to align with PPD IT SOPs.Capture and document software requirements and configurations.Develop validation test cases and protocols related to Instruments/Medical devices, integrations and downstream workflow validationCreate infrastructure and data flow diagrams.Conduct comprehensive risk assessments.Collaborate with cross-functional teams including IT, QA, and lab operations.Required Skills & QualificationsProven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environment.Strong technical writing skills for documentation and test case development.Excellent communication skills to interact with cross-functional teams.Highly detail-oriented with a focus on compliance and accuracy.Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.Experience with risk assessment methodologies and validation lifecycle documentation.What are the top 3 skills required for this role?Insturment / Medical devices software validation Instrument integration and downstream workflow validation Document and validate software installed on lab instruments per EMA regulatory standardsYears Of Experience RequiredMid to Senior Level professionals with 6 10+ years of relevant experience.Prior experience in lab instrumentation software validation is highly desirable.","company":"Saransh","rawCompany":"saransh","city":"Denver","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-08-14T13:20:32.747Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"},{"code":"334516","title":"Analytical Laboratory Instrument Manufacturing","slug":"analytical-laboratory-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Instrument Software validation Engineer - W2 Only","description":"Job Title: Instrument Software validation EngineerLocation- Remote W2 PositionNameCoreLIMSGAMPGxP AssessmentMedical Devices regulationsMedical device developmentSoftware validationCSVKey ResponsibilitiesDocument and validate software installed on lab instruments per EMA regulatory standards.Validate Instruments and Instrument IntegrationMigrate instrument software management to align with PPD IT SOPs.Capture and document software requirements and configurations.Develop validation test cases and protocols related to Instruments/Medical devices, integrations and downstream workflow validationCreate infrastructure and data flow diagrams.Conduct comprehensive risk assessments.Collaborate with cross-functional teams including IT, QA, and lab operations.Required Skills & QualificationsProven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environment.Strong technical writing skills for documentation and test case development.Excellent communication skills to interact with cross-functional teams.Highly detail-oriented with a focus on compliance and accuracy.Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.Experience with risk assessment methodologies and validation lifecycle documentation.What are the top 3 skills required for this role?Insturment / Medical devices software validation Instrument integration and downstream workflow validation Document and validate software installed on lab instruments per EMA regulatory standardsYears Of Experience RequiredMid to Senior Level professionals with 6 10+ years of relevant experience.Prior experience in lab instrumentation software validation is highly desirable.","datePosted":"2026-08-14T13:20:32.747Z","dateModified":"2026-08-14T13:20:32.747Z","hiringOrganization":{"@type":"Organization","name":"Saransh","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"cbccd02689426f1485cefd39"},"url":"https://jobsearcher.com/jobs/cbccd02689426f1485cefd39"}}