Manufacturing Operator
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About The Position
The Manufacturing Operator position at Piramal Pharma Solutions is a critical role within the Pharmaceutical Production department located in Lexington, KY. This position operates on a night shift schedule, working a 12-hour rotating schedule that requires flexibility and commitment. The Manufacturing Operator is responsible for a variety of production-related activities that are essential to the manufacturing process. These activities include component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. The role demands strict adherence to all applicable policies and procedures, particularly those regulated by Piramal Pharma Solutions and various regulatory agencies. In this position, the Manufacturing Operator will perform line clearances, cleaning and sanitization of fill equipment, sterilization of components, and operation of aseptic filling equipment. The operator will also be responsible for filter testing and the operation of vial washing equipment. A key aspect of the role involves weighing, measuring, and checking raw materials to ensure that batches manufactured contain the proper ingredients and quantities. The Manufacturing Operator will execute validation protocols for processes and equipment, maintain records, and ensure a clean environment to comply with regulatory requirements. The role also includes reviewing current Standard Operating Procedures (SOPs) and providing feedback on potential process improvements. Participation in troubleshooting and process improvement activities is expected, along with corresponding documentation activities. The Manufacturing Operator will review completed production documentation for quality and compliance with current Good Manufacturing Practices (cGMP). In the event of process deviations, the operator is expected to initiate appropriate actions. Additionally, the Manufacturing Operator will perform on-the-job training for new and developing operators and routinely maintain cleanliness and routine maintenance of the work area and equipment. Effective collaboration and communication with other functional groups, including quality, validation, and supply chain, are essential to ensure production goals are achieved.
