Description:
This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical injectable products within a regulated sterile manufacturing environment. The position operates and monitors injectable manufacturing equipment and related apparatus to support parenteral product production objectives. It involves the careful handling of raw materials as well as intermediate and finished injectable pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of injectable manufacturing operations including compounding, filling, and related processes in accordance with established formulations and batch manufacturing records. General maintenance activities on injectable manufacturing equipment and related machinery are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the injectable manufacturing function.
Essential Functions:
- Operate and monitor injectable manufacturing equipment and related apparatus in accordance with validated procedures and GMP standards.
- Handle raw materials, intermediate products, and finished injectable goods with care to maintain product quality, sterility, and prevent contamination.
- Perform injectable manufacturing operations including compounding, filling, and related processes per approved batch manufacturing records.
- Mix and compound ingredients for injectable formulations, suspensions, and sterile products per approved procedures.
- Conduct general maintenance on injectable manufacturing equipment and related apparatus to ensure operational readiness.
- Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.
- Participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
Support area cleaning and sanitization activities to maintain a compliant and sterile injectable manufacturing environment.
Additional Responsibilities:
