Packaging 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. The Operator assists in other manufacturing processes for Aveva’s products when manufacturing activities are complete and 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 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, in‑process sampling, testing, and inspection. Perform in‑process quality checks and make adjustments to correct defects. Verify the correctness of all finished laminates and packaging components against the issuance documents to ensure correct materials are used. Document work performed as specified in the batch record. Monitor equipment operation, processing parameters, and product produced. Make minor adjustments for processing parameters within batch record limits. Investigate process problems, notify section leader and supervisors, and take corrective actions. After each run, shut down the line or prepare for lot change as directed in batch records and 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 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. Provide QA support for audits and inspections. Verify 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 and minimize downtime. Maintain packaging lines in a clean and orderly state; perform minor and spot cleaning as required. Safety & Efficiency Follow all safety procedures and protocols to prevent accidents and contamination. Comply with GMP dress code standards 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 Ensure that the packaging DLM boards are updated timely and reflect current information. Alert Packaging Section Leader and Production Supervisor of all process‑related problems so appropriate action can be taken. Perform other duties to meet the department’s production schedule or comply with cGMPs. Work as a member of a team to achieve all outcomes. Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Perform all work in support of our corporate values: Innovate, Evolve and Excel. Job Requirements Education High school diploma or general education development (GED) credential plus a minimum of 3 years of related experience and/or training in manufacturing/packaging (pharmaceutical, food, or general commercial) in a GMP environment. Experience Demonstrate career progression within Aveva with a minimum of 2 years in roles such as Manufacturing Operator I, Blending Operator I, Packaging Inspector Packer I, Packaging Material Handler I, or equivalent related experience. Knowledge, Skills and Abilities Strong mechanical aptitude and problem‑solving skills. Ability to read, write, speak, and comprehend English and to complete batch record documentation. Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions and decimals; calculate rates, ratios, percentages, and plot and interpret data graphically. Be organized, capable of following instructions, and able to coordinate multiple activities simultaneously. Work in a fast‑paced environment and follow detailed instructions. Maintain mental focus and methodical approach to ensure efficient and accurate task completion. Understand the function and operation of common tools and of PLCs and graphical user interfaces on equipment. Familiar with functions of equipment systems utilizing compressed air, electrical supply, vacuum, steam, chilled water, etc. Have basic computer skills including data entry. Physical Requirements and Working Conditions Required to sit, stand, walk, use hand to finger, reach with hands and arms, and talk and hear; occasionally stoop, kneel, crouch, or crawl; frequently lift and/or move up to 50 pounds. Regular exposure to moving mechanical parts; noise level for loud. Use of personal protective equipment such as gloves, masks, and hairnets. May be required to work additional hours, including weekends; shift hours subject to change due to operational needs. #J-18808-Ljbffr Aveva Drug Delivery Systems