IT Validation Specialist

The role

The IT Validation Analyst supports and executes validation activities for GxP-regulated computerized systems. This role ensures systems are implemented, maintained, and operated in compliance with regulatory requirements and company procedures.

What you will do

• 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, URS, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
• Perform risk-based assessments to determine validation scope, testing requirements, and compliance impact.
• Coordinate and execute validation testing activities and document results.
• Maintain and manage validation documentation and test execution activities using VLMS, EDMS, and QMS systems.
• Support Change Controls, Deviations, CAPAs, and Periodic Reviews of GxP computerized systems.
• 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.

Required qualifications

• 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
• 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
• Knowledge and understanding of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity requirements)
• 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
• AI Literacy: working knowledge of AI technologies and approved AI tools

Nice to have

• experience with Computer Software Assurance (CSA) and AI
• Experience with ValGenesis and Veeva Quality Vault
• Validation of AI and/or use of AI in validation activities in a GxP environment

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• eight (8) weeks of paid parental leave after just three (3) months of employment
• paid time off including vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• flexible spending and health savings accounts
• life and AD&D insurance
• short- and long-term disability coverage
• legal assistance
• supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• voluntary commuter benefits
• family planning and care resources
• well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy through a portfolio of innovative technologies.