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

• 35 years experience in CQV/CSV within pharmaceutical biotech or regulated industries.
• Bachelors 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.