Cleanroom Sterile Fill Technician

Fagron Tech; Wichita (KS); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

401(k) plan

Medical, vision and dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking a Cleanroom Fill Technician to assemble finished sterile products while maintaining patient safety and top quality. The role emphasizes keeping the cleanroom in a constant state of cleanliness and ensuring supplies are properly stacked, with detailed documentation and strict aseptic practices.

You will work in a controlled environment, following CGMP guidelines, performing inventory, sterilization, and batch-record documentation.

Qualifications

• High school diploma or equivalent required.
• 1+ year of experience in healthcare, manufacturing, or a similar regulated environment preferred.
• Familiarity with cleanroom procedures and cGMP requirements preferred.
• 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.
• Must successfully complete required cleanroom, gowning, and aseptic technique qualification before handling product and maintain qualification through required periodic requalification.

Responsibilities

• Maintain a sterile cleanroom environment by garbing, cleaning, and following CGMP-aligned procedures.
• Clean equipment in the cleanroom daily and ensure validations are up to date.
• Oversee colleagues using the “tech check tech” process for product assembly, measurements, garbing, sterile techniques, and documentation.
• Take inventory into the cleanroom to identify components needed for production batches.
• Ensure all components entering the clean room are sterile.
• Coordinate with compounding and vial wash to obtain supplies and maintain intra-room communication.
• Document batch records, Climents, lumacs, and cleaning logs.
• Prepare and sterilize components and fill into specified containers.
• Validate garbing standards on a semi-annual basis.
• Complete 3 consecutive media fills with a set minimum of syringes and vials to pass validation every 6 months.
• Follow SOPs 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

Aseptic technique

cGMP knowledge

Documentation

Time management

Independent worker

Education

High school diploma

Tools

Sterilization equipment

Cleanroom PPE

Job description

Fagron is seeking a Cleanroom Fill Technician to assemble finished sterile products while maintaining patient safety and top quality. The role emphasizes keeping the cleanroom in a constant state of cleanliness and ensuring supplies are properly stacked, with detailed documentation and strict aseptic practices.

You will work in a controlled environment, following CGMP guidelines, performing inventory, sterilization, and batch-record documentation.