GxP IT Validation Analyst (CSV/CSA) – Hybrid

Legendcareers; New Jersey; Hybrid; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Flexible spending accounts

Well-being programs

Job summary

Legend Biotech, based in Somerset, NJ, is seeking an IT Validation Analyst to support validation of GxP-regulated systems. You will work with IT, QA, and vendors to ensure systems meet regulatory standards throughout their lifecycle.

The role emphasizes CSV/CSA execution, documentation, risk assessment, and collaboration across teams to maintain validated state and pass internal/regulatory audits.

Qualifications

• Bachelor’s degree in Life Science, IT, Engineering or related field.
• 1–3 years in Computer System Validation (CSV) in biotech/pharma; CSA and AI a plus.
• Knowledge of GxP regulations and data integrity.
• Experience with VLMS/EDMS and QMS.
• Experience in risk-based approaches to CSV/CSA.
• Proven ability to author validation deliverables and procedures.

Responsibilities

• Execute CSV and CSA activities for GxP systems.
• Author and maintain validation documents (URS, test scripts, VSRs).
• Perform risk-based scope determinations for validation.
• Coordinate validation testing, document results, resolve issues.
• Maintain validation docs using VLMS, EDMS; support audits and change controls.
• Provide guidance on validation requirements to project teams.

Skills

CSV experience

CSA experience

AI in validation

GxP compliance

VLMS/EDMS tooling

Risk-based validation

Documentation

Communication skills

Education

Bachelor’s Degree in Life Science/IT/Engineering

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

Legend Biotech, based in Somerset, NJ, is seeking an IT Validation Analyst to support validation of GxP-regulated systems. You will work with IT, QA, and vendors to ensure systems meet regulatory standards throughout their lifecycle.

The role emphasizes CSV/CSA execution, documentation, risk assessment, and collaboration across teams to maintain validated state and pass internal/regulatory audits.