Cleanroom Fill Technician - 2nd Shift

Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient.

About The Job

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.

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 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.
  
  

Basic Qualifications

• 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.
  
  

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.