Lead Manufacturing Technician

Role Summary

The Lead Manufacturing Technician executes all processes in production while following cGMP, environmental health and safety guidelines and related regulations. Manages hands-on production activities under supervision, revises or creates procedures, and supports transfer of new technologies. Demonstrates leadership in cGMP compliance and safety.

Responsibilities

• Lead training and mentoring for manufacturing technician progression from level 1-3
• Conduct safety Gemba observations and coach technicians on ergonomic techniques
• Support local manufacturing operations
• Demonstrate proficiency in electronic systems (e.g., EBM, JDE)
• Operate production equipment (filling, inspection, packaging)
• Ensure paperwork complies with GDP/GMP guidelines
• Manually clean portable equipment and small parts
• Participate on Continuous Improvement Teams
• Receive and distribute supplies to production area
• Monitor daily cleaning to maintain GMP standards; assemble and operate filtration systems
• Prepare components to meet schedule adherence and set up incoming shift for success
• Troubleshoot process and equipment issues to minimize downtime
• Coordinate with maintenance/metrology for preventive maintenance

Qualifications

• High school diploma or GED; 6+ years of experience or AA or higher with 4+ years related work experience
• Understanding of cGMP regulations
• Experience with pharmaceutical production equipment including autoclave
• Ability to apply quantitative analysis to assess process performance
• Proficiency in mathematical disciplines and units in metric and US standards
• Knowledge of chemical and biological safety procedures

Skills

• cGMP compliance
• Production equipment operation
• Process troubleshooting
• Documentation and GDP/GMP adherence
• Electronic systems proficiency
• Safety coaching and training facilitation

Education

• High school diploma or GED; additional AA or higher preferred

Additional Requirements

• Work in controlled environment with gowning and protective clothing; possible respiratory protection
• Multiple shifts including weekends; 12-hour shifts in 2-2-3 rotation may be required
• Possible immunization requirements for manufacturing area