Process Validation Engineer

Position OverviewWe are seeking a Process Validation Engineer to support and execute validation activities within a regulated manufacturing environment. This role will ensure all validation processes are compliant with ISO 13485:2016, regulatory requirements, and internal quality standards. The ideal candidate will work closely with cross-functional teams including Manufacturing Engineering, Quality Assurance, and Supply Chain to drive validation excellence and documentation integrity.Key ResponsibilitiesSupport and participate in Process Risk Management Reviews (PRMRs), including coordination, documentation, and tracking closure of action itemsProvide guidance to Manufacturing Engineers (MEs) on validation strategies, protocols, and industry best practicesReview and approve validation protocols and reports to ensure accuracy, completeness, and regulatory complianceAssist in planning and executing process validation activities (IQ, OQ, PQ) and ensure proper documentationMaintain and update supplier validation matrices ensuring traceability, accuracy, and complianceReview controlled documentation to ensure alignment between electronic systems and approved hard copiesSupport collection and compilation of supplier validation documentation, technical summaries, and reportsCollaborate with Manufacturing Engineering, QA, and Supply Chain teams to support validation initiativesDrive continuous improvement efforts related to validation processes and documentation managementEnsure all validation activities comply with ISO 13485:2016, GMP, and applicable regulatory requirementsRequired QualificationsBachelor’s degree in Engineering or related field3+ years of experience in process validation within Medical Device, Pharma, or Life Sciences industryStrong understanding of process validation lifecycle (IQ/OQ/PQ)Experience with risk management processes (PRMR, FMEA, etc.)Solid knowledge of ISO 13485:2016, GMP, and regulatory compliance standardsExperience reviewing and approving validation protocols and reportsStrong documentation and technical writing skillsAbility to work in a cross-functional, regulated environmentPreferred QualificationsExperience with supplier validation and qualification processesFamiliarity with electronic document management systems (eQMS)Exposure to CAPA, change control, and deviation managementExperience supporting audit readiness and regulatory inspectionsKey SkillsProcess Validation (IQ/OQ/PQ)GMP & ISO 13485 ComplianceRisk Management (FMEA / PRMR)Validation Documentation & ReviewSupplier ValidationCross-functional Collaboration