What are the responsibilities and job description for the GMP Manufacturing Associate position at Takeda Pharmaceutical?
About the Position
The GMP Manufacturing Associate will be responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations.
- 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, etc.)
- 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.
- Train and mentor other team members.
- Write, revise and review pertinent documentation as appropriate.
- Troubleshoot process problems and respond to process alarms.
- Assist with process/equipment validation and data analysis.
- Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
- Initiate and/or coordinate other process improvement projects.
This role requires strong technical knowledge and ability to work in a team environment. The successful candidate will have experience in a manufacturing environment and a strong understanding of cGMP principles.
