Major responsibilities

• Be fully responsible for maintenance and repair of process equipment at Gracell Biotech Co., Ltd. (Suzhou Buildings 8 and 12, and the Shanghai Xinsi PD laboratory); primary base in Suzhou.
• Respond promptly to maintenance and repair requests covering isolators, bioreactors, incubators, sterilizers/autoclaves, biological safety cabinets, as well as QC and PD equipment.
• Assist in establishing and optimizing the equipment lifecycle management system; strictly implement and record activities according to relevant SOPs.
• Be responsible for procurement and inventory management of GMP spare parts for process equipment.
• Execute annual, semi-annual, quarterly, and monthly maintenance for production, QC, warehouse, and PD equipment.
• Participate in user requirements development and design qualification; support equipment acceptance, commissioning, qualification, and validation.
• Participate in quality activities such as deviations, CAPA, and changes.
• Candidates with experience in CAR-T, plasmid, and viral process (upstream and downstream) are preferred.
• Perform other tasks assigned by the manager.

Core Business Skills

• Background and knowledge in GMP equipment management.
• Familiarity with CAR-T, plasmid, and lentiviral vector (LVV) upstream and downstream processes, with relevant hands-on experience.

Education, Qualifications, Skills and Experience

• At least 3 years 'experience in pharmaceutical and 1 years background in Cell or gene therapy industries.
• Education background: Junior college or above Major: Mechanical or electrical.
• Familiar with management procedure of process/Lab equipment, Protective maintenance requirement and emergency maintenance procedure.
• Basic English read and write skill and good computer office software application skills.
• Possess a low-voltage electrician qualification certificate and proficiency in CAD drawing.