CSV Engineer – Bend, Oregon, USA

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Bend (OR); On-site; USD 85,000 - 120,000; Full time

Job summary

AMTSOL is seeking a CSV/CQV Specialist to support high-priority qualification and validation activities within a cGMP environment in Bend, Oregon. The role focuses on qualification of analytical instruments, computerized systems and GMP equipment, and on driving inspection-ready validation documentation and backlog remediation.

You will collaborate with QC, QA, Engineering, Automation, Instrumentation and system owners, manage deviations and change controls, and use Kneat for validation

Qualifications

• 3–5+ years' experience in CQV/CSV within pharmaceutical or regulated industries.
• Bachelor's degree in engineering, life sciences, chemistry or biology.
• Strong GMP/CQV/CSV background.
• Instrumentation and analytical 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.

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.

Skills

CQV/CSV

GMP knowledge

Documentation

Technical writing

Data integrity

Multi-priority

Education

Bachelor's degree

Tools

Kneat

Job 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.

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.