Demonstrated working knowledge of aseptic processing, cleanroom behavior, contamination control, environmental and personnel monitoring concepts, aseptic process simulations/media fills, airflow visualization/smoke studies, Good Documentation Practices, data integrity, deviation investigations, CAPA, and quality risk management. Key Activities/Responsibilities: Maintain a routine, visible presence in classified manufacturing areas and observe gowning, setup, disinfection, material transfer, aseptic connections, line clearance, interventions, environmental and personnel monitoring interfaces, and other high-risk activities.