CQV & CSV Validation Engineer - Onsite Bend, OR

Randstad USA; Bend (OR); On-site; USD 131,000 - 142,000; Part time

Job summary

Randstad USA in Bend, Oregon is seeking a Validation Engineer 2 for a contract role to support CQV and CSV for analytical instruments, cGMP equipment, and computerized systems on-site. You will work to resolve backlogs and ensure regulatory compliance including 21 CFR Part 11 and EU Annex 11.

The role requires 3-5+ years of CQV/CSV experience, a Bachelor's degree, and the ability to work on-site in Bend with potential campus-wide travel. Kneat experience is preferred.

Qualifications

• 3-5+ years of CQV/CSV experience in a cGMP environment.
• Hands-on qualification and computer system validation for analytical lab instruments and cGMP equipment.
• Familiarity with 21 CFR Part 11, EU Annex 11, data integrity, and GxP requirements.
• Experience using Kneat for document creation, workflow routing, and approvals.
• On-site work requirement in Bend, OR and ability to travel between campus buildings.

Responsibilities

• Develop, execute, and review complete validation lifecycle documentation (URS, IQ/OQ/PQ, Risk Assessments, and Summary Reports).
• Perform qualification and CSV for analytical instruments and cGMP equipment.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, data integrity, and GxP standards.
• Utilize Kneat platform for documentation workflows and approvals.
• Collaborate with QA, QC, and Instrumentation teams to manage change controls, deviations, and CAPAs.
• Conduct field execution, resolve discrepancies, and maintain inspection-ready docs.

Skills

CQV experience

CSV experience

Attention to detail

Education

Bachelor's degree

Tools

Kneat

Job description

Randstad USA in Bend, Oregon is seeking a Validation Engineer 2 for a contract role to support CQV and CSV for analytical instruments, cGMP equipment, and computerized systems on-site. You will work to resolve backlogs and ensure regulatory compliance including 21 CFR Part 11 and EU Annex 11.

The role requires 3-5+ years of CQV/CSV experience, a Bachelor's degree, and the ability to work on-site in Bend with potential campus-wide travel. Kneat experience is preferred.