Senior Validation Engineer – Medical Devices

Job Summary

We are seeking a Senior Validation Engineer to support equipment lifecycle management, facility changes, and commercialization activities within a medical device environment. This role will play a key part in ensuring equipment and systems are validated, compliant, and maintained in a validated state throughout their lifecycle.

The ideal candidate will have strong experience in validation documentation, equipment qualification, and cross-functional collaboration within regulated environments.

Key Responsibilities

Validation & Documentation

• 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