CSV/CQV Specialist

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Bend, OR, United States

21 days ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Experienced

Experience required

3 years minimum

Working hours

Regular working hours

Job source

www.thejobnetwork.com

Tech stack

Data Integrity Iq/oq/pq Test Scripts Computerised Systems

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., * 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.