Aseptic Fill Technician — Sterile Manufacturing & Growth

Fagron; Wichita (KS); On-site; USD 25,000 - 39,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health Savings Account (HSA)

Holiday/paid time off

Job summary

Fagron seeks a Cleanroom Fill Technician to assemble finished sterile products, ensuring patient safety and quality. The role maintains a sterile cleanroom and proper supply organization to support production batches.

You will follow CGMP guidelines, perform equipment cleaning and validations, and supervise colleagues through the tech check tech process while documenting batch records and logs. The position requires adherence to aseptic techniques and goblin qualification requirements.

Qualifications

• High school diploma or equivalent required; 1+ year of experience in healthcare, manufacturing, or 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

• Maintains a sterile environment in the cleanroom by garbing, cleaning, and following cleanroom procedures that align with CGMP practices.
• Cleans equipment in the cleanroom daily; ensures equipment validations are up to date.
• Oversees techniques and practices of co-workers through the “tech check tech” process, including product assembly and documentation.
• Take inventory into the cleanroom to identify components needed to fill production batches.
• Ensure all components entering the clean room are sterile.
• Coordinate with compounding and vial wash to obtain supplies and communicate within the cleanroom.
• Document batch records, Climents, lumacs, and cleaning logs.
• Prepare and sterilize components and vials for appropriate solutions; sterilize solutions and fill into containers.
• Validate garbing standards on a semi-annual basis.
• Complete 3 consecutive media fills with minimum syringes and vials to pass validation every 6 months.
• Follow SOPs to package sterile products in final container closure.
• Designate people and hoods for different tasks.
• Establish sterility on products received via pass-through from compounding.

Skills

Attention to detail

Aseptic technique

Documentation

Procedural compliance

Education

High school diploma or equivalent

Job description

Fagron seeks a Cleanroom Fill Technician to assemble finished sterile products, ensuring patient safety and quality. The role maintains a sterile cleanroom and proper supply organization to support production batches.

You will follow CGMP guidelines, perform equipment cleaning and validations, and supervise colleagues through the tech check tech process while documenting batch records and logs. The position requires adherence to aseptic techniques and goblin qualification requirements.