Validation Specialist

Job Title: Senior Validation Engineer (IVD / Medical Devices) About the Role We are looking for a Senior Validation Engineer to lead validation activities for manufacturing processes, equipment, test methods, and computerized systems in a regulated IVD / Medical Device environment. This role ensures compliance with global regulatory standards and supports both new and legacy process validation. Key Responsibilities Execute and lead IQ/OQ/PQ, Test Method Validation (TMV), and CSV (GAMP 5) Develop validation plans, protocols, and reports Perform risk-based validation (ISO 14971), CTQ alignment, and statistical analysis (MSA) Support change control, deviation investigations, and revalidation activities Ensure compliance with ISO 13485, IVDR (EU 2017/746), FDA 21 CFR 820/11 Collaborate with QA, Manufacturing, R&D, QC, and IT teams Support NPI, process transfers, and continuous improvement initiatives Qualifications Bachelor’s or Master’s in Engineering or related field 10+ years of validation experience in Medical Devices / IVD / Pharma Strong hands‑on experience in IQ/OQ/PQ, TMV, and CSV Key Skills Validation lifecycle (process, equipment, methods, systems) Statistical tools (MSA, capability analysis) Strong technical writing and documentation skills Experience in GxP and regulatory environments #J-18808-Ljbffr