CSV Lead
Katalyst Talent Agency
Raritan, NJ, United States
8 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
7 years minimum
Working hours
Regular working hours
Job source
Tech stack
Cloud Computing
Data Migration
System Testing
Iq/oq/pq
GXP
Job description
- 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
Requirements
- 7-10+ years of experience in Computer System Validation (CSV)
- Experience in Pharmaceutical / Biotechnology / Medical Device industry
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