Fill Operator I � 1st Shift

Job description

he Fill Operator I is responsible for performing a full range of activities within controlled manufacturing areas, including parts preparation, compounding/formulation, and aseptic filling operations. The role involves preparing and sterilizing equipment such as parts washers and autoclaves, dispensing raw materials including excipients and active pharmaceutical ingredients (API), and operating compounding tanks and automated filling systems including isolators, filters, and associated equipment. The operator ensures all activities are performed in compliance with cGMP guidelines, SOPs, and approved manufacturing procedures. Responsibilities include completing batch records and logbooks, performing in-process quality checks such as fill weight verification and sample collection, and maintaining cleanliness of equipment and controlled environments. The role also includes assisting with preventive maintenance tasks, reporting process deviations, and escalating maintenance or safety issues to supervisors. Operators must maintain strict adherence to aseptic technique and gowning requirements while working in cleanroom environments and are expected to support production demands, including overtime when required. The position operates in a highly regulated, physically demanding environment with strict quality and safety standards.