CSV Lead
Katalyst CRO · Raritan, NJ · 2 mo ago
On-siteManagementContract
Roles & Responsibilities
- 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
Requirements
- Demonstrate strong leadership and stakeholder communication
- Experience 710+ years in Computer System Validation (CSV)
- Experience in Pharmaceutical / Biotechnology / Medical Device industry