Cleanroom Technician; Fill

Overview

The Aseptic Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensures that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked.

• Maintains a sterile environment in the cleanroom by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines.
• Cleans the equipment in the clean room daily; ensures equipment validations are up to date.
• Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
• Takes inventory in the clean room to identify components needed to fill production batches, as scheduled.
• Ensures all components entering the clean room are sterile.
• Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room.
• Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
• Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.
• Validates that garbing standards have been followed on a semi-annual basis.
• Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months.
• Follows standard operation procedures to package sterile products in their final container closure.
• Designates people and hoods for different tasks.
• Uses appropriate process to establish sterility on products received via pass through from compounding.
• Clock in and out for every scheduled shift in a timely manner.