Mid Level Automation CSV Engineer

Role Overview: The CSV Engineer will be responsible for ensuring that computerized systems used within the organization comply with regulatory requirements and internal quality standards. This role involves developing, writing, and executing Computer System Validation (CSV) protocols, managing documentation, and supporting audits to maintain compliance with GxP and other applicable regulations. Key Responsibilities: Develop and author CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ) on Kneat. Execute validation protocols and document results in accordance with company SOPs and regulatory guidelines via Kneat. Perform risk assessments and impact analyses for computerized systems. Ensure compliance with FDA, EMA, and GAMP 5 guidelines for system validation. Collaborate with Automation teams, Quality, and business stakeholders to ensure systems meet user requirements and compliance standards. Maintain validation documentation and ensure tracea...