CSV Engineer - Bend, Oregon, USA

Advanced Manufacturing Tech Solutions (AMTSOL); Bend (OR); On-site; USD 85,000 - 125,000; Full time

Job summary

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.

The ideal candidate will have 3–5+ years' CQV/CSV experience in pharmaceutical or regulated settings, a related bachelor's degree, strong GMP/CQV/CSV expertise, and hands-on

Qualifications

• 3–5+ years of CQV/CSV experience in pharma or regulated settings.
• Bachelor's degree in engineering, life sciences, chemistry or biology.
• Strong GMP/CQv/CSV background and instrument qualification experience.

Responsibilities

• Support IQ/OQ/PQ for analytical instruments, computerized systems and GMP equipment.
• Develop and execute validation documentation (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 experience

GMP compliance

Kneat

Technical writing

Data integrity

Regulated industries

Education

Bachelor's degree in Engineering or Life Sciences or Chemistry or Biology

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.