The Manufacturing Operator performs functions related to the manufacture of drug products, such as setting-up, cleaning, operating, and maintaining equipment. The role assists in troubleshooting process and equipment issues and observes established escalation paths to ensure issues are appropriately addressed and resolved so production targets can be met.
- The Manufacturing Operator will support and adhere to established manufacturing scheduling processes and production targets.
- Handle raw materials and/or intermediate or finished products according to applicable SOPs.
- Operate pharmaceutical production equipment, for new and existing technologies, in strict accordance with production batch records, SOPs, and cGMPs. This includes Gowning correctly and wearing of assigned PPE, performing start-up and testing of manufacturing equipment, operating and monitoring equipment, performing in process equipment tests, observing varying conditions and adjusting equipment controls as required, and keeping equipment operating by following operating instructions and troubleshooting basic mechanical and automation issues.
- Perform AQL sampling.
- Complete all required production data entries and calculations for manufactured batches on the BMR/PI Sheet/SIC logs with detail and accuracy in real time.
- Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfilment of production goals.
- The Manufacturing Operator will perform master cleans and surface cleans of manufacturing equipment and production areas according to established SOPs and SLAs.
- Execute machine changeovers between batches according to established SOPs and SLAs.
- Seek process innovation and continuous process improvement in production area.
- Complete and conform to all training requirements for job role, including company-required and machine-specific training.
- Carry out and assist in the ongoing training of new and existing personal as required in the area of manufacture.
The next Manufacturing Operator should have a Leaving Certificate as minimum with exposure to pharmaceutical manufacturing equipment or equivalent. You should demonstrate excellent communication skills and time management skills. Experience with tabletting operations would be beneficial.
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