PThe Validation Engineer is responsible for planning, executing, documenting, and managing validation activities, including equipment qualification (IQ/OQ/PQ), process validation, and software/tool validation, in compliance with ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements. /ppThis role ensures that production equipment and processes for Class III implantable medical devices operate within defined parameters, meeting quality and regulatory standards. /ppThe Validation Engineer: /ppb1. Validation activities /b /pulliAuthor, execute, and maintain IQ, OQ, and PQ protocols for production equipment; /liliPlan and perform process validation (prospective, concurrent, retrospective) according to regulatory and internal quality standards; /liliPerform Test Method Validation (TMV) and validation of equipment/software; /liliExecute Process Validation Plans (PVP) and validation protocols; /liliManage re-validation activities following equipment or process changes. /li /ulpb2. Documentation and compliance /b /pulliEnsure proper documentation, review, and approval of validation activities per regulatory requirements and SOPs; /liliParticipate in audits and provide validation documentation; /liliSupport risk management activities, including validation impact assessments. /li /ulpb3. Cross-Functional Collaboration /b /pulliProvide technical expertise for integrating validation engineering into product and manufacturing workflows; /liliCollaborate with RD, Quality, and Manufacturing teams for new product introductions and technology transfers; /liliAssist in transferring manufacturing operations to external or in-house sites; /liliSupport validation-related production and QC activities; /liliHelp develop and improve validation procedures, templates, and training; /liliParticipate in non-conformity investigations, CAPA, and change control processes. /li /ulpb4. Regulatory Compliance Support /b /pulliSupport documentation and submissions (e.g., CE Mark, 510(k), IDE, PMA) with technical insights; /liliAddress quality and compliance issues, including NCRs, CAPAs, and supplier challenges. /li /ulpThe candidate must have: /pulliBachelor’s degree in Biomedical, Mechanical, Chemical Engineering, or related; Master’s preferred; /liliAt least 3 years of validation experience in regulated medical device environments, preferably Class III; /liliKnowledge of ISO 13485, EU MDR, and FDA 21 CFR Part 820; /liliFamiliarity with GxP, risk-based validation, and design control principles; /liliProficiency in Microsoft Office and validation tools; /liliStrong technical writing skills in English; /liliKnowledge of cleanroom qualification and environmental monitoring; /liliUnderstanding of statistical methods (Gage RR, capability studies, sampling); /liliExperience with project management and working with quality systems. /li /ulpWe are also interested in candidates with strong skills in chemistry, biology, and biomaterials. If interested, please email your resume and interests. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr