CSV Lead

Katalyst Talent Agency
Raritan, United States of America
27 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Senior

Job location

Raritan, United States of America

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

About the company

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