IT Validation Analyst: GxP Systems in Biotech R&D

Legend Biotech; New Jersey; Presencial; USD 68.000 - 89.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Parental Leave

Paid Time Off

Company Holidays

HSA/FSA

Descripción de la vacante

Legend Biotech, based in Somerset, NJ, is seeking an IT Validation Analyst to support and execute validation activities for GxP-regulated systems within the R&D Systems team. The role focuses on CSV/CSA, documentation, and ensuring lifecycle compliance across IT and QA partners.

The ideal candidate has 1–3 years in CSV in biotech/pharma, knowledge of FDA/EU GxP, and familiarity with VLMS/EDMS/QMS. This full-time on-site position offers comprehensive benefits and growth in a fast-paced

Formación

• 1–3 years of hands-on CSV in biotech or pharmaceutical industries.
• Experience with CSA and AI in validation is a plus.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data integrity.
• Experience in using electronic systems for QMS, VLMS, and EDMS.

Responsabilidades

• Execute and support CSV and CSA activities for GxP systems.
• Author and maintain validation documentation (plans, URS, test scripts).
• Coordinate validation testing, document results, and resolve issues.
• Support Change Controls, Deviations, CAPAs, and periodic reviews.

Conocimientos

CSV/CSA

GxP knowledge

Regulatory compliance

Documentation

Communication skills

Educación

Bachelor’s Degree in Life Science, IT, or Engineering

Herramientas

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Descripción del empleo

Legend Biotech, based in Somerset, NJ, is seeking an IT Validation Analyst to support and execute validation activities for GxP-regulated systems within the R&D Systems team. The role focuses on CSV/CSA, documentation, and ensuring lifecycle compliance across IT and QA partners.

The ideal candidate has 1–3 years in CSV in biotech/pharma, knowledge of FDA/EU GxP, and familiarity with VLMS/EDMS/QMS. This full-time on-site position offers comprehensive benefits and growth in a fast-paced