Cleanroom Fill Technician

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13441302

## About the Job

The Cleanroom 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.

**Key Responsibilities**

• 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.

• Designate 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.