Machine Operator

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/trouble shootings 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

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 manufacturing, food manufacturing or general commercial manufacturing) in a GMP environment required.

Experience 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.

Knowledge,

Skills and Abilities

Strong mechanical aptitude and problem-solving skills.

Ability to read, write, speak, and comprehend English and complete batch record documentation.

Ability to speak English effectively.

Ability write 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 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…