CQV/CSV Specialist – Validation & GMP Compliance Expert

Advanced Manufacturing Tech Solutions; 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, focusing on instrument and system qualification and on inspection-ready documentation.

The role requires 3–5+ years CQV/CSV experience in regulated industries, a life sciences or engineering degree, and strong technical writing skills; Kneat experience is highly preferred.

Qualifications

• 3–5+ years' CQV/CSV experience in pharmaceutical, biotech, or regulated environments.
• Bachelor's degree in engineering, life sciences, chemistry, biology or related field.
• Strong GMP/CQV/CSV background with hands-on equipment qualification.
• 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

GMP/compliance

IQ/OQ/PQ

Data integrity

Technical writing

Education

Bachelor's degree in Engineering/Life Sciences

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.