What are the responsibilities and job description for the Production Mechanic position at AVEVA DRUG DELIVERY SYSTEMS INC?

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, and 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 document accordingly in batch records. Proactively addressing issues a keeping line within operating parameters and supporting Packaging Machine Operators in order to maintain optimum efficiency
- 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.
- Document the 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:
- 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 Machine Operator to complete line changeovers and batch set-ups.
- Performs routine troubleshooting and minor repairs of packaging and processing equipment..
- Maintain 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 be assigned to assist Engineering Technicians in performing Preventive Maintenance in production equipment as needed
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.
- Complies with all company equipment, safety, OSHA rules and regulations
- Minimize 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.

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 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.
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Production equipment operations and maintenance practices.
- Standard Operating Procedures for equipment operations including safety rules and regulations.
- Ability to read, write, speak, and comprehend English and complete batch record documentation.
- Ability to speak English effectively.
- Ability to 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 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.
- Establishing and maintaining cooperative working relationships with individuals contacted during work.

Physical Requirements and Working Conditions:
- While performing the duties of this job, the employee is regularly required to sit, stand and walk. The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds.
- While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The noise level in the work area is usually loud.
- Use of personal protective equipment (PPE) such as gloves, masks, and hairnets
- The employee may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs.

Qualifications:

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.

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Production Mechanic

What are the responsibilities and job description for the Production Mechanic position at AVEVA DRUG DELIVERY SYSTEMS INC?

Job Summary:

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