Cleanroom Fill Technicians; All Shifts

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.

• 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.

• 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 resources to ensure work is completed on time.

• This position requires standing, walking, and bending for extended periods of time.
• Employees must wear specialized protective clothing—commonly referred to as “gowning” or “garb”—to minimize the risk of contamination.
• Pushing and pulling carts loaded with totes of product.
• The employee must occasionally lift and/or move totes of product weighing over 40 pounds. Team lifting is strongly encouraged.
• The employee will be required to read small print.
• Regular exposure to strong chemical odors and fumes.
• Work may be performed in confined or tight spaces.
• Moderate to high noise levels from machinery…