Fagron Sterile Services US (FSS)
Cleanroom Fill Technician
Fagron Sterile Services US (FSS), Wichita, Kansas, United States, 67232
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 cleanroom daily; ensures equipment validations are up to date.
Follows the tech check process to oversee coworkers' techniques and practices of co‑workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
Takes inventory in the cleanroom to identify components needed to fill production batches, as scheduled.
Ensures all components entering the cleanroom are sterile.
Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the cleanroom, 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 three consecutive media fills with a set minimum of syringes and vials 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 operating 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.
Clocks in and out for every scheduled shift in a timely manner.
Seniority level Entry level
Employment type Full‑time
Job function Information Technology
Industries Pharmaceutical Manufacturing
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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 cleanroom daily; ensures equipment validations are up to date.
Follows the tech check process to oversee coworkers' techniques and practices of co‑workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
Takes inventory in the cleanroom to identify components needed to fill production batches, as scheduled.
Ensures all components entering the cleanroom are sterile.
Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the cleanroom, 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 three consecutive media fills with a set minimum of syringes and vials 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 operating 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.
Clocks in and out for every scheduled shift in a timely manner.
Seniority level Entry level
Employment type Full‑time
Job function Information Technology
Industries Pharmaceutical Manufacturing
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