KH
CSV Lead
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Staff / Principal
- 5 months ago
- ERP
- GxP
5 months ago
Not enough detail in this posting to match
- Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition)
- Perform ERP validation, Data Migration, and Cloud Validation activities
- Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs)
- Ensure compliance with GxP, FDA regulations, and risk-based validation
- Support Acquisitions, Divestitures, and Business Separation projects
- Demonstrate strong leadership and stakeholder communication
Experience:
- 7–10+ years of experience in Computer System Validation (CSV)
- Experience in Pharmaceutical / Biotechnology / Medical Device industry
CSV Lead · Katalyst Healthcares & Life Sciences