More jobs:
CSV Lead
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-05-10
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-05-10
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
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
- Demonstrate strong leadership and stakeholder communication
- 710+ years of experience in Computer System Validation (CSV)
- Experience in Pharmaceutical / Biotechnology / Medical Device industry
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