Hiring: IT Validation Specialist Company: Legend Biotech Location: Somerset, NJ Job Posted Time: 2026-09-02 18:08:04 Target Skills & Keywords : Compliance, R, SAFe, TestNG, Vault About the job Experience: •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. •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. Required Skills: •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. 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, 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 o Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!