Production Mechanic

Machine Operation

• Operates Packaging equipment in accordance with established procedures.
• Maintains batch records during production.
• Proactively addresses issues and keeps the line within operating parameters.
• 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

• Fulfills 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.
• Supports QA for Audits and Inspections.
• Verifies documentation and reports for accuracy.

Set-up & Minor Troubleshooting

• Completes line changeovers and batch set-ups with Packaging Machine Operator.
• 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.
• Assists Engineering Technicians in Preventive Maintenance in production equipment as needed.

Safety & Efficiency

• Follows all safety procedures and protocols to prevent accidents and contamination.
• Complies with GMP dress code standards to minimize cross-contamination.
• Complies with 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.
• 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.

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: 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.