CSV Validation Engineer – CQV in Regulated Pharma
Advanced Manufacturing Tech Solutions (AMTSOL)
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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
Education
Tools
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.
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
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