GxP IT Validation Analyst - CSV/CSA

BioSpace; New Jersey; On-site; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical insurance

401(k) match

Parental leave

Paid time off

Job summary

Legend Biotech is seeking an IT Validation Analyst to support and execute validation activities for GxP-regulated computerized systems within the R&D Systems team based in Somerset, NJ. The role ensures systems are implemented and maintained in compliance with regulatory requirements and company procedures.

The ideal candidate has 1–3 years in CSV in biotech/pharma, knowledge of GxP, and experience with VLMS/QMS/EDMS.

Qualifications

• 1-3 years in Computer System Validation (CSV) within biotech/pharma.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience with automated Validation Lifecycle Management System (VLMS) for ongoing activities.

Responsibilities

• Execute CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (Plans, URS, Risk Assessments, Test Scripts, Traceability Matrices).
• Perform risk-based validation scope assessments and determine testing requirements.
• Coordinate and execute validation testing, document results, and resolve deviations.
• Maintain validation docs using VLMS, EDMS, and QMS systems; support audits and changes.

Skills

CSV validation

CSA experience

GxP regulations

AI in validation

VLMS familiarity

QMS familiarity

Communication skills

Education

Bachelor’s Degree

Tools

ValGenesis

Veeva Vault

VLMS

Job description

Legend Biotech is seeking an IT Validation Analyst to support and execute validation activities for GxP-regulated computerized systems within the R&D Systems team based in Somerset, NJ. The role ensures systems are implemented and maintained in compliance with regulatory requirements and company procedures.

The ideal candidate has 1–3 years in CSV in biotech/pharma, knowledge of GxP, and experience with VLMS/QMS/EDMS.