Sr. Quality Automation and AI CSV Engineer - Windsor, CO

Sr. Quality Automation and AI CSV Engineer

The Senior Automation and AI CSV Engineer will lead the design, implementation, and validation of automated systems and AI-driven solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.

Essential Duties & Responsibilities

• Automation & AI Validation:
• Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA’s CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
• Perform risk assessments and ensure data integrity for AI-driven decision-making systems.
• Author and review validatio...