Must have a minimum 5-7 years manufacturing experience in the Pharma Industry/Degree Preferred
- Works on basic to routine assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).
- Performs moderately complex tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating
- Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
- Performs more complex troubleshooting unassisted
- Works on more complex manufacturing processes and assignments
- Assembles, disassembles and operates aseptic filling equipment and lyophilizer autoloading equipment in classed cleanroom environments.
- Prepares equipment and components for sterilization.
- Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel. Cleans (manually and clean-in-place) and assembles 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 detailed /Oracle (computerized software) and MES transactions in resolving inventory discrepancies.
- Cleans manufacturing areas, including walls, ceilings and floors.
- Creates purchase orders for consumables.
- Completes and maintains documentation related to assigned work, including logbooks, batch records, etc.
- May act as point of contact for a compliance audit.
- Operates drum coater and compression equipment.
- Dispenses ingredients for batches.
- Performs MBR Manufacturing batch report updates.
- Performs manual handling of product loads and unloads tablets