IT Validation Specialist

Merck & Co.; New Jersey; On-site; USD 68,000 - 89,000; Full time

Job summary

Legend Biotech in Somerset, NJ, is seeking an IT Validation Analyst to support validation activities for GxP-regulated computerized systems. You will collaborate with IT, QA and vendors to ensure systems are validated throughout their lifecycle.

The role requires 1–3 years in CSV, knowledge of CSA, and familiarity with VLMS, EDMS and QMS. Experience with AI in validation is a plus. This is a full-time, on-site position with comprehensive benefits.

Qualifications

• Bachelor's degree in Life Science, IT, Engineering or related field.
• 1–3 years of hands-on CSV experience in biotech/pharma; CSA and AI a plus.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience with VLMS, EDMS, QMS and document management systems.

Responsibilities

• Execute and support CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (Plans, URS, Risk Assessments, IQ/OQ/UAT, Traceability Matrices, Validation Summary Reports).
• Perform risk-based assessments to determine validation scope and testing requirements.
• Coordinate and execute validation testing, document results, and address issues/deviations.
• Maintain validation docs using VLMS, EDMS, and QMS; preferably with ValGenesis and Veeva Quality Vault.
• Support Change Controls, Deviations, CAPAs, and Periodic Reviews to keep systems validated.
• Assist during internal and regulatory audits by providing validation documentation.
• Provide guidance to system owners and project teams regarding validation requirements.

Skills

CSV validation

CSA

AI experience

VLMS familiarity

Quality systems knowledge

Documentation skills

Communication skills

Education

Bachelor's degree

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.

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

• 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.

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.

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.