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