Hybrid IT Validation Analyst - GxP CSV/CSA Expert

Legend Biotech EU; Maine; On-site; USD 68,000 - 89,000; Full time

Job summary

Legend Biotech is seeking an IT Validation Analyst for the R&D Systems team in Somerset, NJ. The role supports validation of GxP-regulated computerized systems, ensuring compliance throughout their lifecycle. Collaboration with IT, QA, and vendors is essential.

The candidate will author validation deliverables, perform risk-based assessments, and manage validation testing using VLMS/EDMS/QMS systems, with AI in validation considered a plus.

Qualifications

• 1–3 years of hands-on CSV experience in biotech/pharma.
• CSA knowledge and AI in validation a plus.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data integrity impact.
• Experience using VLMS for validation activities.
• Experience in authoring validation deliverables (plans, specs, test scripts, reports).

Responsibilities

• Execute and support CSV and CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (plans, URS, risk assessments, test scripts, traceability matrices).
• Coordinate validation testing, document results, and resolve issues.
• Maintain validation docs using VLMS, EDMS, and QMS systems; support audits.
• Provide guidance to system owners and project teams on validation requirements.

Skills

CSV validation

CSA validation

AI in validation

GxP compliance

Risk-based methodologies

VLMS/EDMS familiarity

QMS familiarity

Communication skills

Education

Bachelor’s degree in Life Science/IT/Engineering

Tools

ValGenesis

Veeva Quality Vault

VLMS

EDMS

QMS

Job description

Legend Biotech is seeking an IT Validation Analyst for the R&D Systems team in Somerset, NJ. The role supports validation of GxP-regulated computerized systems, ensuring compliance throughout their lifecycle. Collaboration with IT, QA, and vendors is essential.

The candidate will author validation deliverables, perform risk-based assessments, and manage validation testing using VLMS/EDMS/QMS systems, with AI in validation considered a plus.