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The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensures that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked.
Job Responsibility:
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 clean room 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
Takes inventory in the clean room to identify components needed to fill production batches, as scheduled
Ensures 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
Uses 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
Requirements:
High school diploma or equivalent
one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling
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
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationship 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
Nice to have:
Knowledge of clean room procedures
Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations
What we offer:
competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry