GxP IT Validation Analyst | CSV/CSA Specialist

Legend Biotech US; New Jersey; Hybrid; USD 54,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

8 weeks paid parental leave

Paid time off

Job summary

Legend Biotech USA Inc. in Somerset, NJ is seeking an IT Validation Analyst to support Computer System Validation (CSV) and Computer Software Assurance (CSA) for GxP-regulated systems.

You will author validation documents, perform risk-based assessments, and coordinate testing with IT, QA, and vendors to ensure continued compliance. Responsibilities include maintaining validation records in VLMS, EDMS, and QMS, supporting changes and deviations, and aiding during audits.

Qualifications

• Bachelor’s Degree in Life Science, IT, Engineering or related field.
• 1–3 years of hands-on CSV experience in biotech/pharma.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience with VLMS, EDMS, QMS for validation activities.
• Experience with AI in validation a plus.

Responsibilities

• Execute and support CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (plans, URS, risk assessments, test scripts).
• Coordinate validation testing, document results, resolve issues.
• Maintain validation docs using VLMS, EDMS, QMS; support audits and CAPAs.

Skills

CSV/CSA knowledge

Regulatory compliance

Documentation

Testing coordination

GxP systems

Education

Bachelor’s Degree in Life Science/IT/Engineering

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

Legend Biotech USA Inc. in Somerset, NJ is seeking an IT Validation Analyst to support Computer System Validation (CSV) and Computer Software Assurance (CSA) for GxP-regulated systems.

You will author validation documents, perform risk-based assessments, and coordinate testing with IT, QA, and vendors to ensure continued compliance. Responsibilities include maintaining validation records in VLMS, EDMS, and QMS, supporting changes and deviations, and aiding during audits.