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Main Duties: - 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