HHiring Reality
← Legend Biotech US

IT Validation Specialist

Legend Biotech US
Location
Somerset, New Jersey, United States
Posted
24 days ago
Department
R&D Systems
What they actually want (must-haves)
  • 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
  • Knowledge and understanding of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity requirements)
  • Experience in applying risk-based methodologies for CSV/CSA
  • Strong interpersonal, oral and written communication skills
Nice to have
  • Experience with Computer Software Assurance (CSA) and AI
  • Experience utilizing an automated Validation Lifecycle Management System (VLMS)
  • Validation of AI and/or use of AI in validation activities in a GxP environment
  • Familiarity with use of electronic systems for Quality Management (QMS), Validation Lifecycle Management (VLMS), and Document Management (EDMS)
What the job really is

The IT Validation Specialist at Legend Biotech will support and execute validation activities for GxP-regulated computerized systems, ensuring compliance with regulatory requirements. Daily responsibilities include authoring and maintaining validation documentation, performing risk assessments, coordinating validation testing, and assisting during audits. The role requires collaboration with IT, Quality Assurance, and vendors to maintain validated systems throughout their lifecycle.

Benefits
  • Medical, dental, and vision insurance
  • 401(k) retirement plan with a company match that vests fully on day one
  • Eight (8) weeks of paid parental leave after three (3) months of employment
  • Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
  • Voluntary benefits including 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
  • Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs
Things to weigh
  • No specific mention of remote work options, though a hybrid model is indicated
  • The role requires compliance with strict GxP regulations, which may involve high-pressure situations during audits
  • Experience with specific systems like ValGenesis and Veeva Quality Vault is preferred but not mandatory
Job score3/5
Benefits3/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

Applying to Legend Biotech US?

See how your résumé matches this role — and tailor it from what actually gets interviews.