Computer System Validation (CSV) Engineer

Responsibilities:Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices.Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.Support system implementations, upgrades, and periodic reviews.Collaborate with QA, IT, and business users to drive validation strategy.Participate in audits and inspections to demonstrate compliance.Requirements:Bachelor's degree in computer science, Engineering, Life Sciences, or related field.2+ years of hands-on CSV experience in pharma, biotech, or medical device environments.Strong working knowledge of GxP, FDA regulations, and SDLC methodologies.Experience validating cloud-based or SaaS GxP systems is a plus.Excellent documentation, communication, and collaboration skills.