QUALITY ENGINEER

Job description

Description Job Purpose: The Quality Engineer supports aseptic manufacturing operations by executing quality system activities, participating in facility and equipment commissioning, and driving process improvements. This role works cross-functionally with Manufacturing, Engineering, MS&T, and Quality to ensure compliance with cGMP requirements while supporting both development and commercial manufacturing programs. This position includes hands-on involvement in cleanroom environments and requires strong technical, analytical, and documentation skills. Essential Duties and Responsibilities: · Execute and support cGMP operations and project-based work, including commissioning activities, process studies, and quality system initiatives · Participate directly in facility and equipment commissioning activities, including field execution, documentation, and coordination with engineering and operations teams · Support and execute process and product development studies, including data collection, analysis, and documentation · Contribute to technology transfer and scale-up activities, supporting successful transition from development to manufacturing · Participate in cleanroom and control...