Aseptic filling -Manufacturing

• Works on basic assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Performs routine tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.
• Reports to Team Lead on a regular basis on line performance and report any issues that need to be resolved.
• Performs basic troubleshooting of issues and escalates when required.
• Organizes routine tasks in an effective manner.
• Prepares equipment and components for sterilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
• Cleans (manually and clean-in-place), assembles and disassembles equipment for production.
• Performs clean-in-place and sterilization-in-place of tanks.
• Performs annealing and sterile filtrations of products.
• Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line.
• Performs Basic Oracle and MES (Manufacturing Execution System) transactions.
• Cleans manufacturing areas, including walls, ceilings and floors.
• Accurately completes required documentation of events and tasks related to assigned work, including logbooks, batch records, etc.
• Reports variance or deviation from standard procedures to department management.
• Prepares coating solution.

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