1. Arrange team resource to participate in the execution of production related activities throughout the project during the planning/ instaliing/ commissioning/ qualification/ production phase. 2. Manage team resource to successfully complete the production tasks on time. 3. Lead the investigation of any unexpected event occured during EQ or batch production and complete the investigation report. 4. Prepare and imporve production - related SOP/WI to ecsure correct operations and increase prodctivity. 5. Communicate with customers for the technical transfer or inquiry responding 6. Communicate with instrument companies for the purchasing, reparing, and training issues.

1. Prepare the URS/DQ/IQ/OQ/PQ/RQ documents and standard operation procedure of production equiment in injectable plant. 2. Support the investigation of any unexpected event occured during EQ or batch production and complete the investigation report. 3. Assist in technology teansfer, process scale up, process fit, continuous improvement and production troubleshooting. 4. Evaluate and establishing production process satisfying aseptic operation and process requirements, and developing the documents in all required aspects such as BPR. 5. Work with team to produce sterile drug products by aseptic processing and ensure production in compliance with GMP.

1. Testing, adjusting, and optimizing new machines. 2. Optimizing and improving processes. 3. Preparing and executing process, cleaning, and sterilization validations. 4. Preparing and executing equipment IQ, OQ, and PQ. 5. Planning and preparing for pilot production. 6. Equipment operation and troubleshooting. 7. Education and training instructor.