Job Details

Join to apply for the Cleanroom Technician (Fill) - 1st Shift role at Fagron Sterile Services US (FSS)

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

Responsibilities

1. Maintain 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.
2. Clean the equipment in the clean room daily; ensure equipment validations are up to date.
3. Follow the tech check process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
4. Take inventory in the clean room to identify components needed to fill production batches, as scheduled.
5. Ensure all components entering the clean room are sterile.
6. Coordinate and communicate with other departments like compounding and vial wash to obtain supplies needed for product manufacturing; communicate within the clean room, from room to room.
7. Document batch records, air quality measurements, log use, maintenance, cleaning of all equipment, and cleaning logs.
8. Prepare and sterilize components/vials for solutions; sterilize solutions and fill into specified containers.
9. Validate that garbing standards have been followed on a semi-annual basis.
10. Complete 3 consecutive media fills with a set minimum of syringes and vials, established by the quality department, within the required timeframe and under challenging conditions to pass validation every 6 months.
11. Follow standard operating procedures to package sterile products in their final container closure.
12. Designate personnel and hoods for different tasks.
13. Use appropriate processes to establish sterility on products received via pass-through from compounding.
14. Clock in and out for every scheduled shift in a timely manner.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industries: Pharmaceutical Manufacturing

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