IT Validation Analyst: GxP Systems in Biotech R&D
Legend Biotech
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Benefits offered by this job
Job summary
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
Qualifications
- 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.
Responsibilities
- 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.
Skills
Education
Tools
Job description
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
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