Senior Validation Engineer Medical Devices
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Job Location:
Silver Spring, MD - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
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
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
