{"schemaVersion":"jobsearcher.job.v1","id":"8371e5f6c6cd25fe7dacdeb0","url":"https://jobsearcher.com/jobs/8371e5f6c6cd25fe7dacdeb0","canonicalUrl":"https://jobsearcher.com/jobs/8371e5f6c6cd25fe7dacdeb0","title":"Validation Engineer","description":"Sr. Validation Engineer (CQV)Location: U.S. (Hybrid – project-based travel required)Industry: Life Sciences / Pharmaceutical / Medical DeviceEmployment Type: Contract / Project-BasedAbout the RoleJoin a team of engineering and regulatory compliance experts delivering capital project CQV solutions for leading life sciences and pharmaceutical manufacturers. This role supports critical projects that improve manufacturing performance, compliance, and product quality from concept through startup.You'll work directly with clients, vendors, and project teams to deliver high-quality validation and commissioning deliverables in GMP-regulated environments.What You'll DoSupport capital project CQV activities from design through startupWork with clients and vendors during early design to embed compliance, testability, and lifecycle requirementsDevelop User Requirement Specifications (URS) for critical equipment and systemsPerform risk assessments focused on critical quality attributesAuthor and execute validation and FDA compliance documentationManage commissioning & qualification documentation for utilities, facilities, and process equipmentDevelop and execute FAT, SAT, IQ, and OQ protocolsInvestigate and troubleshoot validation-related issuesPrepare detailed validation reports and documentation packagesWork within digital validation tools and modern CQV methodologiesWhat You BringExperience7+ years in validation, commissioning, or CQV rolesExperience in pharmaceutical or medical device GMP environmentsBackground in:Aseptic fill/finish or sterile manufacturing (preferred)Drug substance or drug product systems (e.g., centrifugation, TFF, pooling, inspection, packaging)Utilities, HVAC, or facility qualificationTechnical ExpertiseStrong knowledge of GMP regulations:21 CFR Parts 210, 211, 11EU Annex 1ICH Q7 / Q8 / Q9ISPE Baseline GuidesExperience with:IQ / OQ / PQFAT / SATValidation Master Plans (VMP)Risk assessments, deviations, change controlsURS developmentRisk-based validation approach (C&Q preferred)Skills & ToolsStrong technical writing and communication skillsMicrosoft Office (Excel, Word, Project)AutoCAD (preferred)Ability to manage full project lifecycle (design → startup)","company":"Sterling Engineering","rawCompany":"sterling engineering","city":"Indianapolis","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-06-25T03:44:08.941Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Sr. Validation Engineer (CQV)Location: U.S. (Hybrid – project-based travel required)Industry: Life Sciences / Pharmaceutical / Medical DeviceEmployment Type: Contract / Project-BasedAbout the RoleJoin a team of engineering and regulatory compliance experts delivering capital project CQV solutions for leading life sciences and pharmaceutical manufacturers. This role supports critical projects that improve manufacturing performance, compliance, and product quality from concept through startup.You'll work directly with clients, vendors, and project teams to deliver high-quality validation and commissioning deliverables in GMP-regulated environments.What You'll DoSupport capital project CQV activities from design through startupWork with clients and vendors during early design to embed compliance, testability, and lifecycle requirementsDevelop User Requirement Specifications (URS) for critical equipment and systemsPerform risk assessments focused on critical quality attributesAuthor and execute validation and FDA compliance documentationManage commissioning & qualification documentation for utilities, facilities, and process equipmentDevelop and execute FAT, SAT, IQ, and OQ protocolsInvestigate and troubleshoot validation-related issuesPrepare detailed validation reports and documentation packagesWork within digital validation tools and modern CQV methodologiesWhat You BringExperience7+ years in validation, commissioning, or CQV rolesExperience in pharmaceutical or medical device GMP environmentsBackground in:Aseptic fill/finish or sterile manufacturing (preferred)Drug substance or drug product systems (e.g., centrifugation, TFF, pooling, inspection, packaging)Utilities, HVAC, or facility qualificationTechnical ExpertiseStrong knowledge of GMP regulations:21 CFR Parts 210, 211, 11EU Annex 1ICH Q7 / Q8 / Q9ISPE Baseline GuidesExperience with:IQ / OQ / PQFAT / SATValidation Master Plans (VMP)Risk assessments, deviations, change controlsURS developmentRisk-based validation approach (C&Q preferred)Skills & ToolsStrong technical writing and communication skillsMicrosoft Office (Excel, Word, Project)AutoCAD (preferred)Ability to manage full project lifecycle (design → startup)","datePosted":"2026-06-25T03:44:08.941Z","dateModified":"2026-06-25T03:44:08.941Z","hiringOrganization":{"@type":"Organization","name":"Sterling Engineering","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Indianapolis","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8371e5f6c6cd25fe7dacdeb0"},"url":"https://jobsearcher.com/jobs/8371e5f6c6cd25fe7dacdeb0"}}