Senior Process Equipment Engineer

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.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.