IT Validation Specialist

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Bridgewater New Jersey we are advancing the next generation of cell therapy through a portfolio of innovative technologies including autologous allogeneic and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T) T-cell receptor (TCR-T) natural killer (NK) cell-based therapies and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites we are committed to discovering and developing safe effective and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

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

• Bachelors 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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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.