Senior Aseptic Processing & Contamination Control Consultant

This contract role provides technical leadership for a 2-month project addressing FDA 483 audit findings by reviewing and assessing legacy aseptic fill-finish processes. The consultant will facilitate risk assessment workshops and guide the execution of FMEA models to identify contamination mechanisms and drive risk reduction strategies. The position focuses on non-isolator, manual assembly environments and first air challenges within a sterile manufacturing setting.