Machine Operator Jobs

About The Position

Requirements

• High school diploma or general education development (GED) credential.
• Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing or general commercial manufacturing); or equivalent combination of education and experience.
• Manufacturing/Packaging experience in a GMP environment will be a plus.
• Ability to read English and interpret documents such as safety rules, Standard Operating Procedures batch records and cleaning procedures.
• Ability to write in English and complete batch record documentation.
• Ability to speak English effectively.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Ability to compute rate, ratio, percent and to plot and interpret data graphically.
• Ability to apply common sense understating to carry out detailed written and oral instructions.
• Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements.
• Strong mechanical aptitude and problem-solving skills.
• Ability to read, write, speak, and comprehend English and complete batch record documentation.
• Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions and decimals.
• Ability to compute rate, ratio, percent, and to plot and interpret data graphically.
• Must be organized, capable of following instructions, and have the ability to coordinate multiple activities simultaneously.
• Ability to work in a fast-paced environment and follow detailed instructions.
• Must be able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
• Understand the function and operation of common tools and the operation of PLCs and graphical user interfaces on equipment.
• Must be familiar with functions of equipment systems that operate utilizing multiple utilities such as compressed air, electrical supply, vacuum, steam, chilled water, etc.
• Must have basic computer skills including data entry.

Nice To Haves

• Demonstrate career progression within Aveva with a minimum of 2 years experience as a Manufacturing Operator I, Blending Operator I, Packaging Inspector Packer I, Packaging Material Handler I or equivalent related experience.
• Minimum of 3 years of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing or general commercial manufacturing) in a GMP environment required.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Verifies current raw materials for batches and stages components and dedicated equipment parts for each batch.
• Documents operational parameters and steps performed in the batch record.
• Documents and dispose of all packaging waste on a per shift basis and at the end of each batch.
• Provides components as needed during the packaging of batches.
• Closes, labels, palletizes and transports finished goods.
• Weighs and documents the weight of components.
• Performs standard testing procedures on daily basis.
• Uses a pallet jack to transport finished goods and components.
• Cleans packaging rooms and equipment, and any production area as needed and documents it in appropriate logbooks.
• Supports clinical labeling operations as required.
• Complies with current Good Manufacturing Practices, Standard Operating Procedures and safety policies while performing all job duties.
• Maintains and cleans manufacturing and production areas and equipment per SOP requirements.
• 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.
• Works as a member of a team to achieve all outcomes.
• All other relevant duties as assigned.