Senior Validation Engineer

Now Hiring: Validation Engineer 2 – CSV/CQV Specialist

Bend, OR 97703 | Fully Onsite

Contract: 6–9 Months | Potential Extension/Conversion

Pay: $70.92–$99.29/hour (W2)

Benefits: Weekly Pay Medical, Dental & Vision

We are seeking an experienced Validation Engineer 2 / CSV-CQV Specialist to support a high-priority validation backlog within the CQV organization.

This is an excellent opportunity for a professional with strong CSV/CQV experience, particularly within a pharmaceutical, biotechnology, medical device, or analytical laboratory environment.

Key Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation, including URS, risk assessments, design specifications, traceability matrices, protocols, test scripts, deviations, and summary reports.
• Support qualification and validation of analytical laboratory instruments, computerized systems, and GMP equipment.
• Execute and support IQ/OQ/PQ activities.
• Ensure compliance with GMP, GxP, 21 CFR Part 11, EU Annex 11, and Annex 15 requirements.
• Support change controls, impact assessments, deviations, CAPAs, and validation protocols.
• Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners.
• Use the Kneat validation platform for documentation, workflow routing, approvals, and record closure.
• Support validation backlog remediation and high-volume qualification activities.
• Monitor field execution, identify gaps, resolve discrepancies, and maintain inspection-ready documentation.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.
• 3–5 years of CSV and/or CQV experience in a regulated industry.
• Hands-on experience qualifying analytical laboratory instruments and equipment.
• Experience working in a cGMP environment.
• Experience with computerized systems validation and equipment qualification.
• Strong technical writing and validation documentation skills.
• Ability to manage multiple projects and competing priorities.

Highly Preferred

• Kneat validation/documentation platform experience
• Both CSV and CQV experience
• Analytical laboratory instrumentation experience
• Hands-on IQ/OQ/PQ execution
• Experience supporting validation backlogs or remediation projects
• Strong understanding of 21 CFR Part 11, Parts 210/211, EU Annex 11, Annex 15, USP, and ASTM standards

Ideal Candidate

The ideal candidate is a hands-on CSV/CQV professional who understands the difference between equipment qualification and computerized system validation and can balance documentation responsibilities with field execution.