Job Summary:

The Packaging Machine Operator is responsible for setting up, operating, and performing minor interactions (clearing jams, In-Process cleanings, etc.) with packaging machinery used in the packaging of Aveva’s Transdermal and orally disintegrating film (ODF) products and clinical labeling of developmental products.

Job Responsibilities:

• Machine Operation:
  
  
  
  
  • Set up, operate, and monitor pharmaceutical packaging machines such as pouching, cartoning, labeling, and sealing equipment.
  
  
  • Ensure that machines function efficiently and adjust settings as necessary to maintain productivity and quality.
  
  
  • Follow Batch Record instructions that specify materials, components, labeling, and processing parameters to be utilized, in-process sampling, testing, and inspection, etc.
  
  
  • Perform in-process quality checks and make adjustments to correct defects.
  
  
  • Verifies the correctness of all finished laminates and packaging components against the appropriate issuance documents to ensure that the correct materials are used during the packaging process.
  
  
  • Document the work performed as specified in the Batch Record.
  
  
  • Monitor the operation of the equipment, the processing parameters utilized, and the product produced.
  
  
  • Makes minor adjustments for processing parameters within batch record limits.
  
  
  • Investigates process problems, notifies section leader and supervisors, and takes appropriate corrective actions.
  
  
  • After each run, the Packaging Operator shuts down the line or prepares for lot change as directed in Batch Records and required by the Production Schedule.
  
  
  • Perform product counts, initiate Line Clearance and/or Cleaning Procedures, confirm satisfactory completion and recording of line clearances, equipment and area cleaning, post status and in-process product/lot number labeling, and complete all associated documentation as specified in Batch Records and SOPs.
  
  
  
  


• Quality Assurance & Compliance:
  
  
  
  • Follow all GMP, FDA, and company SOPs related to pharmaceutical packaging operations.
  
  
  • Inspect packaging components and finished products for compliance with specifications.
  
  
  • Maintain accurate documentation of production activities, machine performance, and quality control records.
  
  
  • Provides QA Support for Audits and Inspections.
  
  
  • Verifies documentation and reports for accuracy.
  
  
  
  


• Set-up & Minor Troubleshooting:
  
  
  
  • Work with packaging mechanics to complete line changeovers and batch set-ups.
  
  
  • Clear jams, perform in-process cleanings, and other minor interactions/troubleshootings to ensure efficient operation of the packaging equipment and minimize downtime.
  
  
  • Maintain Packaging Lines in a clean and orderly state. Performs minor and spot cleaning as required.
  
  
  
  


• Safety & Efficiency:
  
  
  
  • Follow all safety procedures and protocols to prevent accidents and contamination.
  
  
  • Complies with GMP dress code standards in order to minimize cross contamination.
  
  
  • Ensure packaging lines operate efficiently by coordinating with production and quality teams.
  
  
  • Minimize waste by optimizing machine operation and material usage
  
  
  
  

 

• General:
  
  
  
  
  • Ensures that the packaging DLM boards are updated timely and reflect current information. 
  
  
  • Alerts Packaging Section Leader and Production Supervisor of all process-related problems so that appropriate action can be taken.
  
  
  • Performs other duties in order to meet department's production schedule or to comply with cGMPs.
  
  
  • Works as a member of a team to achieve all outcomes.
  
  
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
  
  
  • Performs all work in support of our corporate values: Innovate, Evolve and Excel.
  
  
  • All other relevant duties as assigned.