Senior Validation Engineer - Medical Devices

Stark Pharma; Silver Spring (MD); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma in Silver Spring, MD is seeking a Senior Validation Engineer for a 6-month contract with potential extension. The role involves supporting equipment lifecycle management, facility changes, and commercialization activities in a medical device environment. The ideal candidate must have over 5 years of experience in validation documentation, hands-on knowledge of IQ/OQ/PQ processes, and familiarity with GMP and FDA standards. Strong collaboration and problem-solving skills are essential for this position.

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.

Responsibilities

• Develop, review, and execute validation documents including URS, IQ/OQ/PQ, and Final/Summary Reports.
• Support equipment lifecycle validation activities for commercial medical device operations.
• Execute validation protocols and ensure compliance with regulatory standards.

Skills

Validation documentation

Equipment qualification

Cross-functional collaboration

Problem-solving skills

Strong communication skills

Job description

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