北京招聘

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, fermenters, bioreactors, formulation, washing, filling, capping, sterilization, CIP/SIP, and packaging

• Coordinates with project managers to determine project scope, complexity and schedule for project development

• Develops project execution plans (budget, milestones, deliverables and staffing plans) to deliver project on time, on budget and of the highest quality

• Writes scope of work for process, utilities and manufacturing controls based on preliminary reviews with the client

• Complete design deliverables for single unit operations through entire facility flow including, process flow diagrams, material and energy balances, utility requirements and process P&IDs that include controls strategy and CIP/SIP functions, if appropriate

• 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 Fermenters, Bioreactors, CIP / SIP and COP stations, fixed & mobile process vessels, disposable bioreactors and devices

• Complete design for utilities generation and distribution systems. generate P&IDs for critical utility systems, such as WFI, USP purified water, clean steam and process gases

• Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation

• Make use of and participate in development of company design tools including process simulation and smart P&IDs (AutoCAD, Plant 3D, SuperPro, etc.)

• Establish and maintain excellent working relationships with clients and members of the Exyte design team

• 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

Qualifications:

• Minimum of fifteen (15) years engineering experience and a minimum of ten (10) years in bioprocess design, preferably in the pharmaceutical and biotechnology industries

• Experience in the life sciences (pharmaceutical, biotech, nutraceutical, etc.) is preferred

• Experience designing drug substance/product for cell therapy, gene therapy, vaccines, mAB and mammalian is preferred

• Sound knowledge of system design, applicable codes and CGMP’s as they affect process design and equipment specification and knowledge of pharmaceutical production

• Possesses a demonstrated ability for analytical thinking, an aptitude for structured problem solving, superior verbal and written communication skills as well as a strong work ethic

• Must be able to build strong rapport within department and across Exyte disciplines

• Travel may be required as projects are being executed at different parts of China

• Knowledge of Good Manufacturing Practice (GMP)

• Knowledge of equipment design and system specifications, utility system calculations and energy optimizations

• Knowledge of 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

  Exyte提供杰出优越的设计、工程和施工服务，是交付高科技设施和厂房的全球先锋。公司拥有超过100年历史，早已在可控和受控环境方面具备特殊的专业技术。Exyte活跃于全球市场，为半导体、电池、制药、生物技术以及数据中心等对技术要求极高的客户提供从咨询、设计到“交钥匙”工程的全方位服务，交付优秀品质符合最严格安全标准的高科技设施，并与客户建立起了互信、持久的关系。2019年，Exyte集团销售额达到39亿欧元，拥有近5,200名经验丰富、积极进取的员工。