GxP IT Validation Analyst — CSV/CSA Expert (Hybrid)

Legend Biotech USA; Somerset (NJ); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Job summary

Legend Biotech USA is seeking an IT Validation Analyst to support CSV/CSA for GxP-regulated systems in Somerset, NJ. You will author validation documentation, manage testing, and ensure lifecycle compliance across VLMS, EDMS, and QMS.

In this role you will collaborate with IT, QA, process owners, and vendors, perform risk-based scoping, support audits, and provide guidance on validation requirements and best practices in a fast-paced biotech environment.

Qualifications

• 1-3 years of hands-on experience in Computer System Validation (CSV) within biotech/pharma.
• Experience with Computer Software Assurance (CSA) and AI in validation preferred.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

Responsibilities

• Execute and support CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (Plans, URS, Risk Assessments, Test Scripts, Traceability).
• Perform risk-based assessments to determine scope and compliance impact.
• Coordinate validation testing, document results, and resolve deviations.
• Maintain validation docs using VLMS/EDMS/QMS; support Change Controls and CAPAs.
• Assist audits with validation documentation and guidance on best practices.

Skills

CSV

CSA

AI in validation

GxP knowledge

VLMS

EDMS

QMS

Risk-based testing

Documentation skills

Communication skills

Education

Bachelor's degree in Life Science / IT / Engineering

Tools

ValGenesis

Veeva Quality Vault

VLMS

EDMS

QMS

Job description

Legend Biotech USA is seeking an IT Validation Analyst to support CSV/CSA for GxP-regulated systems in Somerset, NJ. You will author validation documentation, manage testing, and ensure lifecycle compliance across VLMS, EDMS, and QMS.

In this role you will collaborate with IT, QA, process owners, and vendors, perform risk-based scoping, support audits, and provide guidance on validation requirements and best practices in a fast-paced biotech environment.