Position Title: Manufacturing OperatorReports to: Production Manager
Department: Operations (PPR)Status: Hourly Non-exempt
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.
• 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.
Signature of Team Member Date
• 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.
• Team player committed to quality and working effectively with others.
• Ability to work in a high demand manufacturing setting.
• Position may require extended hours including evenings and weekend.
• Ability to lift up to 40 pounds, stand for long periods of time, work gowned up for long periods of time, maintain good personal hygiene.
• Visual demand: Correctable vision, equal to or better than 20/20