CSV Engineer - Bend, Oregon, USA

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Bend (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

AMTSOL is seeking a CSV/CQV Specialist to support qualification and validation activities in a cGMP environment. The role focuses on instrument, computerized systems and GMP equipment qualification, and on delivering inspection-ready validation documentation and backlog remediation.

You will collaborate with QC, QA, Engineering and system owners, manage deviations, CAPAs, change controls and validation backlog, and use Kneat for documentation workflows and approvals to ensure compliant,

Qualifications

• Experience CQV/CSV in pharma or regulated industries.
• Hands-on instrument qualification experience.
• Excellent technical writing and documentation skills.

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 experience

Analytical writing

Multitasking

Regulatory mindset

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.