Production Mechanic

Job Details Location: Miramar, FL 33025 Job Summary Under general supervision, the Packaging Mechanic I is responsible for setting up, operating, and performing routine troubleshooting (clearing jams, in‑process cleanings, etc.) and minor repair of all packaging equipment and systems used in the packaging of Aveva’s Transdermal and orally disintegrating film (ODF) products and clinical labeling of developmental products. The role also conducts packaging line changeovers and mechanical set‑up of all packaging equipment in accordance with the packaging schedule. Assists in other manufacturing processes for Aveva’s products when manufacturing activities are complete. Job Responsibilities Machine Operation: Operates packaging equipment in accordance with established procedures. Monitors packaging line during production and documents in batch records. Proactively addresses issues to keep the line within operating parameters and supports packaging machine operators to maintain optimum efficiency. Follows batch record instructions specifying materials, components, labeling, and processing parameters, in‑process sampling, testing, and inspection. Performs in‑process quality checks and makes adjustments to correct defects. Documents work performed as specified in the batch record. Maintains work areas in a clean and orderly manner. Supports department goals for output and efficiencies. Quality Assurance & Compliance: Follows all GMP, FDA, and company SOPs related to pharmaceutical packaging operations. Inspects packaging components and finished products for compliance with specifications. Maintains 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: Works with packaging machine operators to complete line changeovers and batch set‑ups. Performs routine troubleshooting and minor repairs of packaging and processing equipment. Maintains packaging lines in a clean and orderly state, performs minor and spot cleaning as required. Reports all major and unresolved downtime issues to the packaging section leader and escalates to engineering technician. May assist engineering technicians in performing preventive maintenance on production equipment as needed. Safety & Efficiency: Follows all safety procedures and protocols to prevent accidents and contamination. Complies with GMP dress code standards and all company equipment, safety, OSHA rules and regulations. Minimizes waste by optimizing machine operation and material usage. General: Carries out responsibilities in accordance with the organization’s policies and procedures and state, federal and local laws. Alerts engineering technicians, 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. Qualifications Education: High school diploma or 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. Experience: Demonstrated 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. Current knowledge of cGMP, FDA, and other regulatory requirements. Experience with production equipment operations and maintenance practices. Familiarity with standard operating procedures for equipment operations including safety rules and regulations. Ability to read, write, speak, and comprehend English and complete batch record documentation. Mathematical 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 plot and interpret data graphically. Must be organized, capable of following instructions, and able to coordinate multiple activities simultaneously. Must be able 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. Understands the function and operation of common tools and the operation of PLCs and graphical user interfaces on equipment. Familiar with equipment systems that utilize multiple utilities such as compressed air, electrical supply, vacuum, steam, chilled water, etc. Has basic computer skills including data entry. Able to establish and maintain cooperative working relationships with individuals contacted during work. Physical Requirements and Working Conditions Employee is regularly required to sit, stand, and walk; frequently required to use hand to finger, handle or feel, reach with hands and arms, and talk and hear. Occasionally required to stoop, kneel, crouch or crawl. Must frequently lift and/or move up to 50 pounds. Employee is regularly exposed to moving mechanical parts. Noise level is usually loud. Use of personal protective equipment (PPE) such as gloves, masks, and hairnets. Employee may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs. #J-18808-Ljbffr