Fagron Sterile Services US (FSS)
Cleanroom Technician (Fill)
Fagron Sterile Services US (FSS), Wichita, Kansas, United States, 67232
Overview
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Cleanroom Technician (Fill)
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Fagron Sterile Services US (FSS) . 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. 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 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. 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. Seniority level
Entry level Employment type
Full-time Job function
Engineering and Information Technology Industries
Pharmaceutical Manufacturing Wichita, KS $70,000.00-$85,000.00 1 month ago
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Join to apply for the
Cleanroom Technician (Fill)
role at
Fagron Sterile Services US (FSS) . 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. 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 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. 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. Seniority level
Entry level Employment type
Full-time Job function
Engineering and Information Technology Industries
Pharmaceutical Manufacturing Wichita, KS $70,000.00-$85,000.00 1 month ago
#J-18808-Ljbffr