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Computer System Validation Engineer

Katalyst Healthcares and LifesciencesWilmington, DE🇺🇸United StatesPosted 15 Aug 2026

Why This Role Stands Out

This hybrid role offers significant career growth in computer system validation within the reputable Katalyst Healthcares and Lifesciences, allowing you to develop expertise in critical GxP and regulatory compliance areas. You'll thrive here if you possess a strong background in validation documentation and a desire to contribute to impactful projects in the life sciences sector. Apply today to join a forward-thinking team and advance your career in a flexible work environment.

Quick Overview

Work Type
Hybrid
Level
Mid Senior

Job Description

Roles & Responsibilities :
  • 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
  • uthoring of URS/FS, protocols, final reports, validation plan/report
  • High-level understanding of Veeva Vault suits
  • Risk-based testing aligned to CSA fundamentals
  • High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

Education & Experience :
  • Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
  • Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system

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