Senior Validation Engineer, Medical Devices – Onsite

Job Title:

Senior Validation Engineer Medical Devices

Location:

Silver Spring, MD (Onsite)

Duration: 06 months contract (High potential for extension)



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

• 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