PpThe Validation Engineer is responsible for the planning, execution, documentation, and lifecycle management of validation activities, including equipment qualification (IQ/OQ/PQ), process validation, and software/tool validation, in compliance with ISO 13485, EU MDR (Medical Device Regulation), and FDA 21 CFR Part 820 requirements. /ppThis role is essential to ensuring that production equipment and processes used for Class III implantable medical devices consistently operate within defined parameters and meet quality and regulatory requirements. /ph3Responsibilities /h3pbThe Validation Engineer: /b /pulliValidation activitiesulliAuthor, execute, and maintain IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for production equipment; /liliPlan and perform process validation (including prospective, concurrent, and retrospective) in accordance with regulatory and internal quality requirements; /liliPerform Test Method Validation (TMV) and equipment/software validation; /liliExecute the Process Validation Plans (PVP) and validation protocols; Validation activities. /liliManage re-validation activities upon equipment or process changes. /li /ul /liliDocumentation and complianceulliEnsure all equipment qualification and validation activities are properly documented, reviewed, and approved according to regulatory requirements (e.g., ISO 13485, GMP, FDA) and internal SOPs; /liliParticipate in internal and external audits and provide validation documentation as required; /liliSupport risk management activities, including validation impact assessments. /li /ul /liliCross-Functional CollaborationulliProvide technical expertise in integrating validation engineering into product and manufacturing workflows. /liliWork closely with RD, Quality, and Manufacturing teams to support new product introductions and technology transfers; /liliAssist in the transfer of manufacturing operations to external contract manufacturers or in-house commercial manufacturing sites; /liliMay be effectively involved in production and QC activities during validation and/or process development and/or validation. /li /ul /liliSupport the development and improvement of validation procedures, templates, and training; /liliParticipate in non-conformity investigations, CAPA processes, and change control processes. /liliRegulatory Compliance SupportulliSupport documentation and regulatory submissions (e.g., CE Mark, 510(k), IDE, PMA) by providing technical insights on process design and validation; /liliAddress and remediate quality and compliance issues, including NCRs, CAPAs, and supplier quality challenges. /li /ul /li /ulh3Requirements /h3ulliBachelor’s degree in Engineering (Biomedical, Mechanical, Chemical, or equivalent) or a related technical discipline; an advanced degree (Master’s) is preferred; /liliMinimum of 3 years of experience in validation within regulated medical device environment, 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; /liliProven ability to execute cross-functional technical projects; /liliStrong technical writing and documentation skills in English; /liliKnowledge of cleanroom qualification and environmental monitoring; /liliUnderstanding of statistical methods (e.g., Gage RR, capability studies, sampling plans); /liliSuccessful experience with project and program management. Proven experience working with quality system tools and professionals to ensure highly reliable processes. /li /ulpWe keep an eye out for people with strong skills in chemistry, biology and biomaterials as openings occur. If you would like to be considered for openings in these areas, please email your resume and interests to /p /p #J-18808-Ljbffr