IT Validation Specialist

Legend Biotech US; New Jersey; Hybrid; USD 54,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

8 weeks paid parental leave

Paid time off

Job summary

Legend Biotech USA Inc. in Somerset, NJ is seeking an IT Validation Analyst to support Computer System Validation (CSV) and Computer Software Assurance (CSA) for GxP-regulated systems.

You will author validation documents, perform risk-based assessments, and coordinate testing with IT, QA, and vendors to ensure continued compliance. Responsibilities include maintaining validation records in VLMS, EDMS, and QMS, supporting changes and deviations, and aiding during audits.

Qualifications

• Bachelor’s Degree in Life Science, IT, Engineering or related field.
• 1–3 years of hands-on CSV experience in biotech/pharma.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience with VLMS, EDMS, QMS for validation activities.
• Experience with AI in validation a plus.

Responsibilities

• Execute and support CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (plans, URS, risk assessments, test scripts).
• Coordinate validation testing, document results, resolve issues.
• Maintain validation docs using VLMS, EDMS, QMS; support audits and CAPAs.

Skills

CSV/CSA knowledge

Regulatory compliance

Documentation

Testing coordination

GxP systems

Education

Bachelor’s Degree in Life Science/IT/Engineering

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

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.

IT Validation Analyst

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.

#Li-FB1

#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$68,045 - $89,308 USD

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

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.

I (the candidate) enter into thisNon-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc.(the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me.

• Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information.
• Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know‑how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
• Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
• Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
• General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California. This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

Please print your name if you agree to the terms and conditions set forth in the applicant Non-Disclosure Agreement.