at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
About the job
The Aseptic Automation Technician will operate automated manufacturing equipment used to create products with a focus on patient safety and quality; they will ensure that equipment is operating appropriately to meet manufacturing demand.
Responsibilities:
• Responsible for the operation and maintenance of automated filling equipment.
• Performs setup, teardown, and cleaning of automated equipment.
• Maintains cleanroom conditions, by gowning, sanitation, and behaving according to procedures that align with cGMP practices or guidelines.
• Ensures that assigned equipment validation activities are up to date.
• Help assess performance of equipment and aid in trouble shooting for any challenges that arise.
• Takes inventory to identify components needed to fulfil production batches, as scheduled.
• Coordinates and communicates with compounding and dispensing to obtain supplies needed to turn products; communicates with both the aseptic and post-production teams.
• Document batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs appropriately.
• Ensures that gowning standards have been maintained on a semi-annual basis.
• Performs initial and routine qualifications for equipment, including media fills, if required.
• Follows standard operation procedures for the completion of assigned tasks.
• Clock in and out for each scheduled shift in a timely manner.
