IT Validation Analyst — CSV/CSA for GxP Systems

Initial Therapeutics, Inc.; New Jersey; On-site; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Paid time off and parental leave

Flexible spending accounts and health‑

Savings accounts

Job summary

Legend Biotech in Somerset, NJ, seeks an IT Validation Analyst to support and execute validation activities for GxP-regulated computerized systems. You will work with IT, QA, business owners, and vendors to ensure validated systems remain compliant throughout their lifecycle.

The role requires 1–3 years of CSV/CSA experience in biotech/pharma, knowledge of GxP regulations, and strong documentation skills. Experience with VLMS/QMS/EDMS tools and AI in validation is a plus.

Qualifications

• Bachelor’s degree in a Life Science, IT, Engineering or related field.
• 1–3 years’ hands-on CSV experience in biotech/pharma.
• Knowledge of QA, IT, Learning Management, Lab, Facilities, Equipment, Mfg.
• Experience with VLMS/EDMS/QMS for validation and testing.
• Experience with AI in validation in a GxP environment is a plus.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity.
• Risk-based CSV/CSA methodologies and deliverables.
• Experience authoring validation plans, specs, scripts, reports.
• Familiar with electronic QA systems and document management.

Responsibilities

• Validate GxP-regulated computerized systems via CSV/CSA.
• Create and maintain Validation Plans, URS, Risk Assessments, and test scripts.
• Coordinate testing, document results, resolve issues and deviations.
• Maintain validation docs using VLMS, EDMS, and QMS systems.
• Support Change Controls, Deviations, CAPAs, periodic reviews.
• Assist audits with validation documentation and guidance.
• Guide owners and project teams on validation requirements.

Skills

CSV

CSA

GxP

AI in validation

Data Integrity

Risk-based validation

Documentation

IQ/OQ/UAT

Validation lifecycle tools

Education

Bachelor's degree in Life Science/IT/Engineering

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

Legend Biotech in Somerset, NJ, seeks an IT Validation Analyst to support and execute validation activities for GxP-regulated computerized systems. You will work with IT, QA, business owners, and vendors to ensure validated systems remain compliant throughout their lifecycle.

The role requires 1–3 years of CSV/CSA experience in biotech/pharma, knowledge of GxP regulations, and strong documentation skills. Experience with VLMS/QMS/EDMS tools and AI in validation is a plus.