Sterile Fill Technician - Cleanroom Aseptic Assembly

Fagron Tech; Wichita (KS); On-site; USD 42,000 - 65,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, vision & dental coverage

Health savings account (HSA)

Job summary

Fagron is seeking a Cleanroom Fill Technician to assemble finished sterile products while upholding patient safety and quality. The role focuses on maintaining a pristine cleanroom, proper garbing, and strict aseptic practices to ensure sterility across production batches.

The work involves documenting batch records, performing routine room validations, and coordinating with compounding and vial wash teams to maintain supply readiness.

Qualifications

• High school diploma or equivalent required.
• Familiarity with cleanroom procedures and cGMP requirements preferred.
• Strong attention to detail with focus on quality, accuracy, sterility, and aseptic technique.

Responsibilities

• Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to cleanroom 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 tech” process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
• Take inventory into the cleanroom to identify components needed to fill production batches, as scheduled.
• Ensure 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 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 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.
• Use appropriate process to establish sterility on products received via pass through from compounding.

Skills

Attention to detail

Sterile technique

GMP knowledge

Team collaboration

Education

High school diploma or equivalent

Job description

Fagron is seeking a Cleanroom Fill Technician to assemble finished sterile products while upholding patient safety and quality. The role focuses on maintaining a pristine cleanroom, proper garbing, and strict aseptic practices to ensure sterility across production batches.

The work involves documenting batch records, performing routine room validations, and coordinating with compounding and vial wash teams to maintain supply readiness.