Validation Engineer 2

Validation Engineer 2 – CSV/CQV Specialist Location: 1201 NW Wall Street, Bend, OR 97703
Work Model: Full-Time, Onsite
Contract Duration: 6–9 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $70.92–$99.29/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance

Position Overview Our client is seeking a Contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. This role will focus on the validation of analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams
.
The ideal candidate will have strong CSV and CQV experience
, preferably within an analytical laboratory or pharmaceutical/biotechnology environment. This position requires someone who can effectively manage competing priorities, produce high-quality validation documentation, and participate in hands‑on qualification and field execution activities.
Onsite presence in Bend, Oregon is required.
Hiring Manager Priorities

• Immediate need due to a significant CQV validation backlog
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• Strong preference for candidates with analytical laboratory experience
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• Candidates with both CSV and CQV experience are highly preferred.
• Must be comfortable balancing priorities between CQV and Instrumentation teams
  .
• Must be willing to work onsite in Bend to support instrument qualification and field execution activities.
• Previous experience with backlog remediation or high-volume validation activities is highly desirable.

• Develop, execute, review, and maintain validation lifecycle documentation, including:
  • Risk Assessments
  • User Requirements Specifications (URS)
  • Design Specifications
  • Traceability Matrices
  • Test Scripts
  • Validation Protocols
  • Discrepancies and Deviations
  • Summary Reports
  • Periodic Review Documentation
  • System Retirement Documentation
• Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.
• Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.
• Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.
• Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.
• Utilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.
• Assist with Kneat template development and continuous improvement initiatives.
• Maintain inspection‑ready documentation in accordance with SOPs, GxP requirements, and site procedures.
• Monitor field execution activities, identify gaps, drive discrepancy resolution, and elevate issues as needed.
• Provide support to the Instrumentation team for CSV activities and the CQV team for qualification execution, documentation updates, and readiness activities.
• Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification.
• Perform other duties as assigned.

• 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.
• Experience supporting qualification of analytical laboratory instruments and equipment
  .
• Experience working in a cGMP-regulated environment
  .
• Experience with computerized systems validation and equipment qualification.
• Experience managing multiple validation projects and competing priorities.
• Experience supporting validation backlogs or high-volume validation activities is highly desirable.

• Hands‑on experience with Kneat validation/documentation software
  .
• Strong understanding of GMP documentation requirements and validation practices.
• Knowledge of:
  • GxP…