CSV Engineer - Bend, Oregon, USA

CSV Engineer - Bend, Oregon, USA 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. Key Responsibilities • 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. Requirements • 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.