Senior Process Engineer

1.Be deep understanding on the related process and equipment, could handle or lead team to implement the manufacturing supporting activities independently, e.g. to solve the complex problem of process or machine, support machine optimization, co-work with supplier to analysis raw material issue. (15%)

对相关工艺和设备有深刻的理解，能都单独处理或带领团队完成较为复杂的生产支持行为，如解决较复杂的工艺或设备问题，支持设备的优化改进，配合供应商完成原材料问题的分析等。(15%)

2.To take responsibility of Suzhou site productivity project independently and ensure the delivery to meet the predetermined requirements.(15%)

可以独立负责并运转苏州工厂的生产力提升的项目，并确保最终交付可以满足预设要求。(15%)

3.To co-work with related function department to build the robust process by increasing the capability of the equipment and process to cover the possible existing variance in operation and raw material.(15%)

与相关功能部门合作来建立强健的工艺，通过增强设备和工艺的能力来克服操作和原材料中可能存在的变异。(15%)

4.To support the equipment design and to optimize manufacturing process and product lines. It is expected that where necessary technical activities will be undertaken and would encompass generation of all associated documentation.(10%)

对生产设备的设计提供支持，并生产工艺及生产线进行优化。计划并执行相关的技术活动和生成相应的文件体系。(10%)

5.Establish and sustain the procedure, work instruction and related record form which for supporting manufacturing, meet the requirements of company, GMP and relevant standards.(5%)

建立并维护用于支持生产相关的程序，指导文件以及相关的记录表单，符合公司，GMP以及相关标准的要求。(5%)

6.To provide the major interface between the different function teams ensuring that technical work task is compliant, and that the file is suitable for audit by FDA, BSI, and other respective regulatory bodies.(5%)

在不同的功能团队中提供主要的接口以确保所有的分技术任务能够被理解完成并所有的文件符合FDA， BSI 和其他的法规要求。(5%)

7.To develop an understanding of customer needs in order to generate and evaluate potential technical solutions for example raw material changes or review and revision of process due to customer complaints.(10%)

研究客户需求，以便生成和评估潜在的技术方案，例如新原料的变更或由于客户的投诉产生的工艺版本更新的审核。(10%)

8.Could handle the change control and validation of complex project.(15%)

可以负责较为复杂项目的变更控制和验证活动。(15%)

9.To promote health and safety policies and procedures to encourage a safe working environment.(5%)

积极执行与健康，安全政策有关的活动和程序以配合促进安全的工作环境。(5%)

10.To perform all activities in compliance with relevant Quality Systems Standards. (5%)

遵照相关的质量体系要求和标准，执行所有的活动。(5%)