IT Validation Specialist

Role Overview

The IT Validation Analyst supports and executes validation activities for GxP-regulated computerized systems. This role ensures systems are implemented, maintained, and operated in compliance with regulatory requirements and company procedures.

Key Responsibilities

• Execute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.
• Author and maintain validation documentation, including: Validation Plans, User Requirements Specifications (URS), Risk Assessments, Test Scripts (IQ/OQ/UAT), Traceability Matrices, and Validation Summary Reports.
• Coordinate and execute validation testing activities, document results, and ensure timely resolution of testing issues and deviations.
• Maintain and manage validation documentation and test execution activities using VLMS, EDMS, and QMS systems.
• Support Change Controls, Deviations, CAPAs, and Periodic Reviews of GxP computerized systems to ensure systems remain in a validated state.
• Ensure compliance with applicable regulations, standards, and guidance.
• Afford guidance to system owners and project teams regarding validation requirements and best practices.

Requirements

• Bachelor’s Degree in a Life Science, IT, Engineering or a related field.
• 1-3 years of hands-on experience in Computer System Validation (CSV) within the biotech or pharmaceutical industries, experience with Computer Software Assurance (CSA) and AI a plus.
• Knowledge of Systems and Processes supporting: Quality, IT, Learning Management, Laboratory, Facilities, Equipment, and/or Manufacturing.
• Experience utilizing an automated Validation Lifecycle Management System (VLMS) for executing and managing periodic activities, validation deliverables, and testing activities.
• Demonstrated experience executing validation projects, creating and maintaining deliverables.
• Knowledge and understanding of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity requirements) and their impact on CSV/CSA.
• Experience in applying risk-based methodologies for CSV/CSA.
• Experience in authoring validation deliverables (plans, specifications, test scripts, reports) and corresponding procedures.
• Familiarity with use of electronic systems for Quality Management (QMS), Validation Lifecycle Management (VLMS), and Document Management (EDMS).
• Strong interpersonal, oral and written communication skills.