Senior Validation Engineer - Medical Devices

Key Responsibilities

• Develop, review, and execute validation documents including: User Requirement Specifications (URS), Validation Determination Assessments (VDA), Installation, Operational, and Performance Qualifications (IQ/OQ/PQ), Requirements Traceability Matrix (RTM), Final/Summary Reports.
• Support equipment lifecycle validation activities for commercial medical device operations.
• Execute validation protocols and ensure compliance with regulatory standards.

Required Qualifications

• Minimum 5+ years of experience in validation within medical device or regulated environments.
• Strong experience with equipment lifecycle management and validation documentation.
• Hands-on experience with IQ/OQ/PQ, URS, RTM, and validation reporting.
• Experience supporting commercialization, facility changes, or system transitions.
• Knowledge of GMP, FDA, and quality system requirements.
• Strong collaboration, communication, and problem-solving skills.