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Position title: Product Engineer产品工艺工程师 Working Location: Xi’an, Shaanxi Welcome to consult through Wechat/mobile phone: 15619388335(Alice) Compensation & Benefit: negotiable Job Purpose: The primary responsibility of the Product engineer will be to lead different aspects in technical transfer as part of the Technical Transfer Team for the Xian relocation project. The process engineer will be supporting the process development, process modeling, characterization validation batches, as well as supporting with the regulatory filing of the related products. You will be part of a fast moving team and will also be acting as a counterpart with different supporting organization as there are engineering, operation, C&Q, quality and automation. Major Responsibilities: Ø Provide the technical support and solutions Ø Work in association of the technical team on the transfer of the product Ø Develop CARs, FMEAs, pilot studies Ø Assist during the product transfer. Ø Assist other technicians to set up technical standards, which can become a benchmark. Ø Be prepared to resolve any trouble that crops up with the machine and process. Ø Generating data to support the modeling Ø Leading characterization and validation exercises Ø Evaluating analytical results Required competencies Ø Bachelor degree or above in engineering, such as Biological engineer, chemical engineering, Mechanic engineering or Automation etc Ø At least 5 years pharmaceutical experience in a development or production environment Ø Experience in product engineering is a must Ø Have a good understanding of the regulatory aspect impacting a tech transfer of products Ø Should be capable of understanding the various issues related to the machine like, testing, analysis of its failure, how to debug it etc. Ø Should possess good understanding about pharmaceutical products Ø Good oral English & team work spirit to communicate in a global environment
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