Cleanroom Fill Technician (Mon-Thurs 11p-9a)

Fagron•Wichita, KS

About The Position

The Cleanroom Fill Technician assembles finished sterile products with a focus on patient safety and quality. The technician maintains cleanroom cleanliness and organization, follows cleanroom procedures aligned with cGMP practices or guidelines, and prepares, sterilizes, and fills components and solutions into specified containers. The role also supports production supply coordination, equipment and process documentation, sterile product packaging, and verification of coworkers’ techniques and practices. The position works in cleanrooms and other controlled compounding and production areas. It requires following hand hygiene, garbing, gowning, and entry procedures and using appropriate PPE. Work involves extended periods of standing and walking, with sitting, bending, and reaching also required. Employees may encounter pharmaceutical ingredients, cleaning agents, disinfectants, chemical odors, active production equipment, and moderate to high noise. Occasional lifting or moving of materials, supplies, or equipment weighing up to 40 pounds may be required; team lifting is encouraged when appropriate. The listed schedule is Monday through Thursday, 11 p.m. to 9 a.m. Fagron describes an open, dynamic environment and opportunities for personal and professional growth.

Requirements

High school diploma or equivalent.
Strong attention to detail with a focus on quality, accuracy, sterility, and aseptic technique.
Ability to follow established procedures, prioritize tasks, manage time effectively, and adapt to changing priorities.
Ability to work independently and collaboratively while maintaining positive, professional relationships with coworkers and management.
Ability to meet the physical and controlled-environment working conditions described, including occasional lifting or moving of materials, supplies, or equipment weighing up to 40 pounds.

Nice To Haves

At least one year of experience in healthcare, manufacturing, or a similar regulated environment.
Familiarity with cleanroom procedures and cGMP requirements.

Responsibilities

Maintain a sterile cleanroom environment by garbing, cleaning the room, and following cleanroom procedures aligned with cGMP practices or guidelines.
Clean cleanroom equipment daily and ensure equipment validations are up to date.
Follow the “tech check tech” process to oversee coworkers’ product assembly, measurements, garbing, sterile techniques, and documentation.
Take inventory into the cleanroom to identify components needed for scheduled production batches.
Ensure all components entering the cleanroom are sterile.
Coordinate and communicate with compounding and vial wash to obtain supplies needed to turn products, and communicate between cleanroom rooms.
Document batch records, Climents (measurements of air in the room), lumacs (equipment use, maintenance, and cleaning logs), and cleaning logs.
Prepare and sterilize components and vials for appropriate solutions; sterilize solutions and fill them into specified containers.
Validate that garbing standards have been followed semi-annually.
Complete three consecutive media fills every six months, meeting the quality department’s minimum syringe and vial requirements within the established time frame and under the most difficult operating conditions.
Follow standard operating procedures to package sterile products in their final container closure.
Designate people and hoods for different tasks.
Use the appropriate process to establish sterility on products received via pass-through from compounding.
Successfully complete required cleanroom, gowning, and aseptic technique qualification before handling product, and maintain qualification through required periodic requalification.