PKG Machine Operator

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. This role ensures that all packaging processes comply with Good Manufacturing Practices (GMP), safety standards, and company policies while maintaining efficiency and quality control. Assists in other manufacturing processes for Aveva’s products when manufacturing activities are complete. Packaging Machine Operators will train to qualify in all the specific duties and responsibilities applicable to each Packaging Line, on a line-by-line basis.

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.

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