Machine Operator

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

50d•Onsite

About The Position

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. This role involves assisting in the packaging and clinical labeling of Aveva’s transdermal and transmucosal products through handling and transfer of raw material, packaging components and equipment parts. It also includes assisting in other packaging processes for Aveva’s products when packaging activities are complete.

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.