職位描述
職位職能:
??生物工程/生物制藥??
職位描述:
JOB TITLE: BRM Engineer
Location: Shanghai
1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible for implementation of new products/processes transfer to production, providing technical support and/or improvements to existing products/processes, and participating in change control process and root cause investigation for manufacturing respecting IP/know-how ground rules.
(1) Provide technical support for new transferred products in BRM production activities and involve in change control and troubleshooting including optimizing production processes in order to increase capacity or reduce costs;
(2) Use knowledge of techniques and methods such as Project Management, Risk Analysis (e.g. FMEA), Problem Solving Methods (e.g. Lean 6 Sigma) to create protocols and present reports on conducted experiments, transferred products and failure investigations and troubleshooting breakdown. Establish and modify the necessary documentation to facilitate production, including SAP data creation to ensure production activities are compliant to site procedure and regulatory requirement;
(3) Participate in Project Meeting to take action and follow-up with respect of timing identified in responsible work package;
(4) Take an active part in new equipment qualification and maintenance;
(5) Coordinate with other departments and assure effective communication to drive the project progress;
(6) Other tasks as defined in related company procedures or assigned by the direct superior.
2. KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
(1) Bachelor in biochemistry with minimum 3 years experience in biological materials or master degree in biology/biochemistry or related disciplines
(2) Experience with techniques of biochemistry coupling, antibody purification, viral culture or hybridomas cell culture; capable of operation equipment like AKTA system, HPLC analysis, SDS-PAGE and IEF (isoelectric focusing)
Education & Knowledge:
(1) Knowledge of manufacturing processes including in-process control, Microplate ELISA and Rapid Tests
(2) Fluent English both written and oral
