Manufacturing Technician II

Role Summary

Manufacturing Technician II at Takeda. Execute all production processes in compliance with cGMP, environmental health and safety guidelines, and applicable regulations. Lead production activities, perform complex troubleshooting, and assist in transferring new technologies into manufacturing. Demonstrate leadership in cGMP compliance and safety.

Responsibilities

• Knowledge of cGMP manufacturing.
• Knowledge of basic laboratory and pharmaceutical production equipment including autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
• Prepare media and buffer solutions.
• Operate Clean-in-Place (CIP) and Steam-in-Place systems.
• Assemble and operate filtration systems.
• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers).
• Monitor and record critical process parameters.
• Complete all relevant paperwork following GDP/GMP guidelines.
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
• Perform sampling using aseptic techniques.
• Participate on Continuous Improvement Teams.
• Mentor other team members.
• Write, revise and review important documentation.
• Troubleshoot process problems and respond to process alarms.
• Help with process/equipment validation and data analysis.
• Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
• Initiate and coordinate other process improvement projects.

Qualifications

• Requires high school diploma or GED plus 2+ years of experience or associates' degree or higher and 1+ years of related work experience.

Skills

• Knowledge of cGMP manufacturing.
• Experience with basic laboratory and pharmaceutical production equipment and systems.
• Strong documentation and data analysis skills.
• Leadership and mentorship abilities.

Education

• High school diploma or GED; associates or higher preferred.

Additional Requirements

• Work in a controlled environment with gowning and protective clothing; potential hearing protection in loud areas.
• Ability to lift up to 50 lbs, push/pull >100 lbs with equipment assistance; stand for long periods.
• Work multiple shifts, including weekends; possible overtime.
• Potential immunization and working with various chemicals requiring respiratory protection.
• Work in cold, wet environments; may involve confined spaces and clean room conditions.