5 - 7 years experience • Biotech/Pharma
**Manufacturing Tech III - Lead / Sr. Tech with minimum 4 years’ experience**
· 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 auto loading 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.