C2C Opening for Medical Device Senior Validation Engineer

Location: Silver Spring, MD (Onsite)
Duration: 06/01/2026 – 12/31/2026 (High possibility of extension)
Experience: 5+ Years
Job Type: Contract / C2C / W2

---

🔹 Position Overview

We are seeking a Senior Validation Engineer with strong experience in medical device validation and equipment lifecycle management. The ideal candidate will support validation activities for commercial device launches, facility changes, and equipment/system transitions while ensuring compliance with regulatory and quality standards.

---

🔹 Key Responsibilities

✔ Validation & Documentation

• Develop, review, and execute validation documentation:
  • User Requirement Specifications (URS)
  • Validation Determination Assessments (VDA)
  • IQ / OQ / PQ protocols
  • Requirements Traceability Matrix (RTM)
  • Summary / Final Reports
• Ensure compliance with validation lifecycle standards

---

✔ Equipment Lifecycle & Facility Support

• Support lifecycle management for medical device equipment
• Assist with commercial launch readiness and system transitions
• Support facility expansion and equipment qualification efforts

---

✔ On-site Coordination & Stakeholder Management

• Act as point of contact for:
  • Validation contractors
  • Operations team
  • Quality Assurance (QA)
• Pre-review validation documents before QA submission
• Lead investigations for protocol deviations and discrepancies

---

✔ Quality & Compliance

• Maintain validated state of equipment post calibration/maintenance
• Execute validation protocols and periodic review cycles
• Ensure minimal disruption to clinical operations

---

✔ Asset & Equipment Management

• Manage equipment lifecycle using Blue Mountain RAM system
• Track calibration, preventive maintenance (PM), and asset documentation
• Ensure alignment of equipment identification and lifecycle tracking

---

🔹 Required Skills

• 5+ years of experience in Medical Device Validation / CQV / CSV
• Strong experience in IQ, OQ, PQ execution
• Knowledge of equipment lifecycle management
• Experience with URS, VDA, RTM, validation reports
• Familiarity with GxP / FDA / regulatory compliance
• Experience with Blue Mountain RAM or similar asset management tools
• Strong documentation, communication, and coordination skills

---

🔹 Preferred Skills

• Experience in perfusion systems / clinical equipment
• Prior experience supporting facility expansion or device launch
• Strong collaboration with QA and clinical teams