{"schemaVersion":"jobsearcher.job.v1","id":"82d9b297c4a3ac8629a3a921","url":"https://jobsearcher.com/jobs/82d9b297c4a3ac8629a3a921","canonicalUrl":"https://jobsearcher.com/jobs/82d9b297c4a3ac8629a3a921","title":"Validation Engineer","description":"Roles & Responsibilities:\n\nWe are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.\n\nCandidates must have strong hands‑on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.\n\nA solid working knowledge of regulatory frameworks is essential — specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 — along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.\n\nExperience with PFMEA and change control impact assessments is also expected.\n\nOn the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.\n\nFamiliarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.\n\nStrong technical writing skills are a must — this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.\n\nCross‑functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day‑to‑day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Somerville","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-07-07T03:57:45.591Z","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":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Roles & Responsibilities:\n\nWe are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.\n\nCandidates must have strong hands‑on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.\n\nA solid working knowledge of regulatory frameworks is essential — specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 — along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.\n\nExperience with PFMEA and change control impact assessments is also expected.\n\nOn the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.\n\nFamiliarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.\n\nStrong technical writing skills are a must — this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.\n\nCross‑functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day‑to‑day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.\n\n#J-18808-Ljbffr","datePosted":"2026-07-07T03:57:45.591Z","dateModified":"2026-07-07T03:57:45.591Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions 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