IT Validation Specialist

Legend Biotech is seeking an IT Validation Analyst as part of the R&D Systems team based in Somerset, NJ. 

Role Overview

The IT Validation Analyst is responsible for supporting and executing validation activities for GxP-regulated computerized systems. This role ensures systems are implemented, maintained, and operated in compliance with regulatory requirements and company procedures. The analyst works closely with IT, Quality Assurance, Business Process Owners, and vendors to ensure validated systems remain compliant throughout their lifecycle.

Key Responsibilities

• Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.
• Author and maintain validation documentation, including:
  
  • Validation Plans
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Test Scripts (IQ/OQ/UAT)
  • Traceability Matrices
  • Validation Summary Reports
• Perform risk-based assessments to determine validation scope, testing requirements, and compliance impact.
• Coordinate and execute validation testing activities, document results, and ensure timely resolution of testing issues and deviations.
• Maintain and manage validation documentation and test execution activities using VLMS, EDMS, and QMS systems. Experience with ValGenesis and Veeva Quality Vault preferred.
• Support Change Controls, Deviations, CAPAs, and Periodic Reviews of GxP computerized systems to ensure systems remain in a validated state.
• Ensure compliance with applicable regulations, standards, and guidance.
• Assist during internal and regulatory audits by providing validation documentation and support.
• Provide guidance to system owners and project teams regarding validation requirements and best practices.

Requirements

• Bachelor’s Degree in a Life Science, IT, Engineering or a related field
• 1-3 years of hands-on experience in Computer System Validation (CSV) within the biotech or pharmaceutical industries, experience with Computer Software Assurance (CSA) and AI a plus.
• Knowledge of Systems and Processes supporting: Quality, IT, Learning Management, Laboratory, Facilities, Equipment, and/or Manufacturing.
• Experience utilizing an automated Validation Lifecycle Management System (VLMS) for executing and managing periodic activities, validation deliverables, and testing activities.
• Demonstrated experience executing validation projects, creating and maintaining deliverables.
• Validation of AI and/or use of AI in validation activities in a GxP environment a plus. 
• Knowledge and understanding of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity requirements) and their impact on CSV/CSA
• Experience in applying risk-based methodologies for CSV/CSA
• Experience in authoring validation deliverables (plans, specifications, test scripts, reports) and corresponding procedures
• Familiarity with use of electronic systems for Quality Management (QMS), Validation Lifecycle Management (VLMS), and Document Management (EDMS).
• Strong interpersonal, oral and written communication skills.

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