The role of the manufacturing operator is to perform production activities including Equipment preparation, Formulation, Filling, Inspection, and Packaging. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.
- High school education or equivalent.
- BS in Biology, Microbiology, Chemistry, Bio-Tech or Engineering preferred (current students may apply).
- Experience in an aseptic manufacturing environment preferred.
- Must be familiar with a variety of production equipment.
Line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
- Operate and maintain production equipment.
- Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
- Execute validation protocols for processes and equipment.
- Maintain records and a clean environment to comply with regulatory requirements.
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Review/update current SOPs as well as write new SOPs.
- Lead troubleshooting and process improvement activities including corresponding documentation activities.
- Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
- Initiate appropriate action when process deviations occur.
- Perform on job training for new and developing operators.
Other duties as assigned by leadership team.