Cleanroom Fill Technicians (Multiple Shifts)

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 38,000 - 52,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Wichita, KS is seeking a Cleanroom Fill Technician to assemble finished sterile products with a focus on patient safety and quality. The role requires maintaining a sterile cleanroom and proper garbing, following CGMP procedures and supporting batch documentation.

The successful candidate will participate in equipment cleaning, validation, and daily inventory to ensure uninterrupted production.

Qualifications

• High school diploma or equivalent required.
• 1–4 years experience in hospital/manufacturing aseptic filling is preferred.
• Knowledge of CGMP is preferred but not required.
• Must pass validation three consecutive times before handling product in clean room; re-qualification every 6 months.

Responsibilities

• Maintains a sterile environment in the cleanroom, garbing, cleaning, and adhering to clean room procedures and guidelines.
• Cleans equipment daily and ensures validations are up to date.
• Oversees tech check tech process for coworker techniques and documentation.
• Takes inventory into the cleanroom to identify components needed for production batches.
• Ensures all components entering the clean room are sterile.
• Coordinates with compounding and vial wash to obtain supplies and communicates within the clean room.
• Documents batch records, environment measurements, log maintenance and cleaning.
• Prepares and sterilizes components and fills into containers.
• Completes validation milestones as required by Quality.

Skills

Attention to detail

Teamwork

Independent work

Education

High school diploma or equivalent

Job description

Who We Are

Since 1990, we've grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. We're passionate, science-driven, and always looking for new ways to improve lives.

About The Job

The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensure that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked.

Key Responsibilities

• Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room 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 clean room, 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.
• Clock in and out for every scheduled shift in a timely manner.

Basic Qualifications

• High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling.
• Knowledge of cleanroom procedures preferred but not required.
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations preferred but not required.
• Must pass validation three consecutive times before handling product in clean room; must be re-qualified every 6 months with a minimum requirement of filling a set minimum of syringes and vials in an Established Time Frame And Difficult Operation Conditions. Preferred But not required.
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize re