IT Validation Specialist
The IT Validation Specialist at Legend Biotech US plays a pivotal role within the R&D Systems team, ensuring that GxP-regulated computerized systems are validated and maintained in compliance with regulatory standards and company procedures. This position is based in Somerset, New Jersey, at Legend Biotech's headquarters, a global biotechnology company dedicated to developing innovative cell therapies for life-threatening diseases. The company is renowned for its commitment to advancing cell therapy through technologies such as CAR-T, TCR-T, and NK cell-based therapies.
In this role, the IT Validation Specialist is responsible for executing and supporting Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems. Key duties include authoring and maintaining validation documentation such as Validation Plans, User Requirements Specifications (URS), Risk Assessments, Test Scripts (IQ/OQ/UAT), Traceability Matrices, and Validation Summary Reports. The specialist performs risk-based assessments to determine validation scope and testing requirements, coordinates and executes validation testing activities, and ensures timely resolution of testing issues and deviations. Additionally, the role involves maintaining validation documentation and test execution activities using systems like VLMS, EDMS, and QMS, and supporting Change Controls, Deviations, CAPAs, and Periodic Reviews to ensure systems remain in a validated state.
Candidates for this position should possess a Bachelor's Degree in a Life Science, IT, Engineering, or a related field. A minimum of 1-3 years of hands-on experience in Computer System Validation within the biotech or pharmaceutical industries is required, with experience in Computer Software Assurance (CSA) and AI being advantageous. Applicants should have 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 validation activities is essential. Familiarity with GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements, is crucial. Strong interpersonal, oral, and written communication skills are also necessary.
Legend Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) retirement plan with company match, and eight weeks of paid parental leave after just three months of employment. The company also provides a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven company holidays. These benefits reflect Legend Biotech's commitment to supporting the well-being and work-life balance of its employees.
At Legend Biotech, the company culture is driven by core behaviors such as Ownership and Commitment, Agility and Prioritization, Teamwork and Communication, and Continuous Improvement. These values are embedded in the company's recruiting, performance, recognition, and development processes. Employees are encouraged to take responsibility for their results, make informed decisions quickly, appreciate diverse perspectives, and embrace change. This culture fosters a collaborative and supportive environment, providing opportunities for personal and professional growth.