Production Sterile - Vial Washing - Operator
Job Description
Machine Operation: Operate automatic high-speed vial washing machines (Linear or Rotary), ensuring correct mechanical settings for various vial sizes (2ml to 100ml).
Utility Management: Monitor and document the pressure and temperature of WFI (Water for Injection), Purified Water, and Compressed Air used in the cleaning cycles.
Depyrogenation Coordination: Ensure a seamless transfer of washed vials into the Depyrogenation Tunnel and monitor the synchronized speed between the washer and the tunnel.
In-Process Checks: Perform regular visual inspections of washed vials for "water spots," breakage, or remaining particles, and conduct "Breakage Calculation" for each batch.
Documentation & BMR: Maintain real-time entries in Batch Manufacturing Records (BMR), equipment logbooks, and utility consumption charts.
Sanitization & Compliance: Perform "Type A/B" cleaning of the washing machine and area; strictly adhere to Grade D/C cleanroom protocols and gowning standards.