The 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. This role is essential to ensuring that production equipment and processes used for Class III implantable medical devices operate within defined parameters and meet quality and regulatory standards. The Validation Engineer: 1. Validation activities Author, execute, and maintain IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for production equipment; Plan and perform process validation (prospective, concurrent, retrospective) according to regulatory and internal quality standards; Perform Test Method Validation (TMV) and validation of equipment/software; Execute Process Validation Plans (PVP) and validation protocols; Manage re-validation activities following equipment or process changes. 2. Documentation and compliance Ensure proper documentation, review, and approval of all qualification and validation activities per regulatory standards (ISO 13485, GMP, FDA) and SOPs; Participate in internal and external audits, providing validation documentation as needed; Support risk management activities, including validation impact assessments. 3. Cross-Functional Collaboration Provide technical expertise in integrating validation engineering into product and manufacturing workflows; Collaborate with R&D, Quality, and Manufacturing teams to support new product launches and technology transfers; Assist in transferring manufacturing operations to external contract manufacturers or in-house sites; Contribute to production and QC activities during validation or process development; Support the development and improvement of validation procedures, templates, and training materials; Participate in non-conformity investigations, CAPA processes, and change controls. 4. Regulatory & Compliance Support Assist in documentation and regulatory submissions (e.g., CE Mark, 510(k), IDE, PMA) by providing technical insights; Address and resolve quality and compliance issues, including NCRs, CAPAs, and supplier quality challenges. The Validation Engineer must have the following requirements: Bachelor’s degree in Engineering (Biomedical, Mechanical, Chemical, or related field); an advanced degree (Master’s) is preferred; Minimum of 3 years of validation experience in a regulated medical device environment, preferably Class III; Knowledge of ISO 13485, EU MDR, and FDA 21 CFR Part 820; Familiarity with GxP, risk-based validation, and design control principles; Proficiency in Microsoft Office and validation tools; Proven ability to lead cross-functional technical projects; Strong technical writing and documentation skills in English; Knowledge of cleanroom qualification and environmental monitoring; Understanding of statistical methods (e.g., Gage R&R, capability studies, sampling plans); Experience with project and program management, working with quality system tools and professionals to ensure reliable processes. We seek individuals with strong skills in chemistry, biology, and biomaterials for future openings. If interested, please email your resume and interests. J-18808-Ljbffr J-18808-Ljbffr