Participate in engineering project teams to design aseptic and biotech processing facilities with specific emphasis in one or more of the following: upstream/downstream processing, formulation, washing, filling, capping, sterilization, CIP/SIP, and packaging
Feasibility studies up to detailed engineering
Perform specification and design, installation, start-up and commissioning; turnover of documentation, and validation activities
Process evaluation and optimization
Development of URS, technical specifications, request for quotation, technical analysis and commercial evaluation of offers, follow-up of construction, pre-operational testing, installation commissioning and validation
Experience in design through qualification of Fermentors, Bioreactors, CIP / SIP and COP stations, fixed & mobile process vessels, disposable bioreactors and devices
Experience in Clean Utility, CS, PTW, WFI, Clean gasses, Equipment and system specifications, consumption calculations, energy optimizations
Successfully interface with clients, project managers, and engineering professional and coordination between client, suppliers and sub-contractors
cGMP/TGA/ISO 9000/EHS internal audits
Define and review validation , qualification and GMP complains related regulations , code and standards ( CFDA and international GMP shall be considered )
Coordinate with design team for DQ review and design GMP upgrade
Other tasks assigned by Department manager
Requirements
Bachelor’s Degree : Chemical Engineering / Chemistry / Bio-medical Engineering
15 years related experiences
Sound knowledge of pharmaceutical production
Knowledge of Good Manufacturing Practice (GMP)
Equipment design and system specifications
Utility system calculations and energy optimizations
Installation, start-up and commissioning; handover of documentation activities
Proficiency in spoken and written Chinse and English.
Diligence to solve problems and finish the work in a structured manner
Global mindset and enjoy working in a multi-cultural environment
Result-oriented and have a well-structured approach to your work
You have a personal drive and are passionate about your work
以担保或任何理由索要财物，扣押证照，均涉嫌违法。
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