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CSV Engineer

Company

Katalyst Healthcares & Life Sciences

Location

South Plainfield, New Jersey, United States

Posted

May 07, 2026

Position Overview

Responsibilities:

  • Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).

  • Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.

  • Providing leadership, oversight, and training related to validation activities to multi-functional teams.

  • Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).

  • Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.

  • Working with appropriate teams to establish quality expectations related to validation planning and execution.

  • <...

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