Qualification Engineer

• Lead commissioning and qualification activities for clean utilities, process gases, and controlled rooms
• Define and execute sampling and monitoring strategies for utility and environmental systems
• Coordinate internal teams and external vendors for testing, commissioning, and analytical services
• Prepare and maintain qualification documentation such as protocols, acceptance criteria, and summary reports
• Perform GMP risk assessments for quality-critical infrastructure and cleanroom utilities
• Own deviations and corrective actions in collaboration with Quality functions
• Act as subject matter expert for changes, investigations, training, and interfaces with QC
• Establish routine monitoring, trending, and continuous improvement programs for utilities and environments

Qualification

• Several years of experience in CQV, microbiology, and lifecycle management of clean utilities, rooms, ...