Filling and Capping Operator

The Filling & Capping Operator position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.

Requirements

• Understand and follow current Good Manufacturing Practices (GMP)
• Understand and follow current Good Documentation Practices (GDP)
• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas
• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches
• Perform routine verification of equipment and instruments
• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch
• Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom areas
• Perform environmental monitoring; including fingertip, contact, and fallout plates
• Assist in the training and development of other team members
• Maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime may be required
• Successful operator qualification/media fill performance required to achieve increased operator levels