Senior Validation Engineer

Tailored Management; Bend (OR); On-site; USD 98,000 - 136,000; Full time

Benefits offered by this job

Weekly Pay

Medical, Dental & Vision

Job summary

Tailored Management in Bend, OR is hiring a Validation Engineer 2 / CSV-CQV Specialist to support a high-priority validation backlog. The role focuses on CSV/CQV in pharma/biotech/medical device contexts, requiring IQ/OQ/PQ execution and GMP/GxP compliance. Expect 6–9 month duration, W2 pay, and on-site work in a fast-paced environment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology or related field 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.

Responsibilities

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

Skills

CSV/CQV experience

Technical writing

Project management

GxP compliance

Validation documentation

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology

Tools

Kneat Validation Platform

Computerized systems validation tools

Job description

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

• 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.