About this role
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.
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