Validation (CSV) Associate

Role: Computer System Validation (CSV) Associate supporting GxP computerized systems in manufacturing, quality control, and regulated business areas. Responsibilities: develop, review, execute, and maintain validation documentation; support system implementation, upgrades, and lifecycle management; ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5; collaborate across QA, QC, IT, Manufacturing, and Regulatory teams; assist in audits, discrepancy investigations, CAPAs, change controls, and system reviews; support data integrity, user access, vendor assessments, and validation records management. Requirements: Bachelor's in Computer Science, Life Sciences, or related field; 2+ years in CSV, Quality Systems, or IT compliance within regulated environments; experience with validated systems in pharma, biotech, or medical devices; knowledge of compliance standards, validation protocols, and systems such as LIMS, QMS, Veeva Vault, TrackWise; familiarity with IT infrastructure, cybersecurity, audit trail review, electronic signatures, and cloud-based applications; strong technical writing, organizational, and communication skills. Preferred: experience supporting SaaS systems and knowledge of cybersecurity concepts. High-Value: regulated biotech/pharma environment, validation of manufacturing and laboratory systems, GxP compliance, audit readiness. Work setup: not specified; likely office-based with cross-functional collaboration.