Biotech IT Validation Analyst (CSV/CSA, GxP)

Merck & Co.; New Jersey; On-site; USD 68,000 - 89,000; Full time

Job summary

Legend Biotech in Somerset, NJ, is seeking an IT Validation Analyst to support validation activities for GxP-regulated computerized systems. You will collaborate with IT, QA and vendors to ensure systems are validated throughout their lifecycle.

The role requires 1–3 years in CSV, knowledge of CSA, and familiarity with VLMS, EDMS and QMS. Experience with AI in validation is a plus. This is a full-time, on-site position with comprehensive benefits.

Qualifications

• Bachelor's degree in Life Science, IT, Engineering or related field.
• 1–3 years of hands-on CSV experience in biotech/pharma; CSA and AI a plus.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience with VLMS, EDMS, QMS and document management systems.

Responsibilities

• Execute and support CSV/CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (Plans, URS, Risk Assessments, IQ/OQ/UAT, Traceability Matrices, Validation Summary Reports).
• Perform risk-based assessments to determine validation scope and testing requirements.
• Coordinate and execute validation testing, document results, and address issues/deviations.
• Maintain validation docs using VLMS, EDMS, and QMS; preferably with ValGenesis and Veeva Quality Vault.
• Support Change Controls, Deviations, CAPAs, and Periodic Reviews to keep systems validated.
• Assist during internal and regulatory audits by providing validation documentation.
• Provide guidance to system owners and project teams regarding validation requirements.

Skills

CSV validation

CSA

AI experience

VLMS familiarity

Quality systems knowledge

Documentation skills

Communication skills

Education

Bachelor's degree

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

Legend Biotech in Somerset, NJ, is seeking an IT Validation Analyst to support validation activities for GxP-regulated computerized systems. You will collaborate with IT, QA and vendors to ensure systems are validated throughout their lifecycle.

The role requires 1–3 years in CSV, knowledge of CSA, and familiarity with VLMS, EDMS and QMS. Experience with AI in validation is a plus. This is a full-time, on-site position with comprehensive benefits.