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# CSV/CQV Specialist

- **Company:** Advanced
- **Location:** Bend, OR, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Iq/oq/pq, Test Scripts, Computerised Systems
- **Published:** September 12, 2026
- **Apply:** https://www.thejobnetwork.com/job/96d43563-dd82-47c9-a584-e8b8949b6a4d/csv-engineer-bend-oregon-usa

## About the Role

* 3-5+ years' experience in CQV/CSV within pharmaceutical, biotech or regulated industries.
 * Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology or a related field preferred.
 * Strong GMP / CQV / CSV background.
 * Analytical laboratory instrument qualification experience.
 * Hands-on equipment qualification experience.
 * Kneat experience strongly preferred.
 * Excellent technical writing and documentation skills.
 * Able to manage multiple priorities in a fast-paced environment.

## Description

AMTSOL is seeking a CSV/CQV Specialist to support high-priority qualification and validation activities within a cGMP environment. The role focuses on the qualification of analytical instruments, computerized systems and GMP equipment, and on driving inspection-ready validation documentation and backlog remediation., * Support IQ/OQ/PQ for analytical instruments, computerized systems and GMP equipment.

 * Develop and execute validation documentation, including URS, risk assessments, protocols, test scripts, traceability matrices and reports.
 * Support CSV, data integrity, 21 CFR Part 11, EU Annex 11 and GMP compliance.
 * Partner with QC, QA, Engineering, Automation, Instrumentation and system owners.
 * Manage deviations, CAPAs, change controls and validation backlog activities.
 * Use Kneat for validation documentation, workflows and approvals.
 * Help drive inspection-ready documentation and backlog remediation.


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