Role & Responsibilities
· Be responsible for the introduction, installation, debugging and verification of laboratory automation equipment for macromolecular biologics;
· Develop and optimize automated experimental processes to improve experimental efficiency and data reliability;
· Responsible for routine maintenance, troubleshooting and performance optimization of automated equipment to ensure stable operation of equipment;
· Compile equipment operation SOPs and provide technical training for laboratory personnel;
· Working with R & D, Manufacturing and Quality to ensure that the automated process complies with GMP/GLP requirements;
· Track industry automation technology development and evaluate and introduce suitable new equipment or technology solutions.
Qualification
Education
- Bachelor degree or above in Automation, Mechanical Engineering, Bioengineering, Pharmaceutical Engineering or related disciplines
Experience
- More than 3 years of experience in the operation, maintenance or management of automated equipment, familiar with laboratory automation systems (such as Hamilton, Tecan, Beckman, etc.)
- Understanding the experimental flow of macromolecular biologics (e.g., monoclonal antibodies, recombinant proteins) is preferred
Skills
- Master PLC programming (Siemens, Mitsubishi, etc.), mechanical control systems;
- Device control and data acquisition can be achieved using LabVIEW, Python, or C#
- Having the fault diagnosis and maintenance ability of electromechanical integration equipment;
- Be able to master GMP/GLP specifications and write equipment IQ/OQ/PQ validation documents
- Understand FDA 21 CFR Part 11 and other data integrity requirements
- Good documentation ability and ability to independently complete SOPs and technical reports