Production Engineer

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

工艺工程师直接汇报给生产经理，是生产部门的技术代表和现在技术问题解决者，也是生产部人员管理和能力提升的重要支持。工艺工程师从生产角度维持工艺稳定性；协调解决生产现场问题，完成工艺相关偏差和投诉。

Process engineer reports directly to the production manager and serves as the technical representative and current technical problem solver for the production department.

He/She will support production supervision to improve floor personnel capability. Process engineers maintain process reliability from a production perspective; Coordinate and resolve floor issues, complete process related deviations and complaints.

主要职责 / MAIN ACCOUNTABILITIES

  工艺工程 Process Engineering:

• 生产工艺控制及优化：

Process control and Optimization

• 通过现场数据收集(CPV数据)和现场观察，控制并稳定生产工艺，并寻求改善机会

Through floor data collection (CPV data) and observation, control and stabilize processes, and seek opportunities for improvement

• 就生产过程中出现的工艺异常、偏差和波动提供反馈，并提供生产角度的技术分析和改进建议，包括：工艺参数优化、良率与设备稳定性提升、人为错误风险降低支持现场 5S 和 GMP 检查准备等

Provide feedback on process abnormalities, deviations, and variance occurring during production, and offer technical analysis and improvement suggestions from production perspective, including optimizing process parameters, improving yield and equipment stability, reducing human error risks, supporting floor 5S and GMP inspection readiness, etc

• 负责生产部门技术层级KPI数据分析和改进

Be responsible for production department technical KPI data analysis and improvement

•   技术角度解决生产现场问题：

Floor issue resolving from technical perspective

• 作为试剂产品量产阶段的现场工艺支持，第一时间解决现场问题，支持日常生产运行

As floor process supports the mass production stage of reagent products, he/she supports daily production operations as 1st tier to solve floor issues

• 作为桥梁连接现场和工业化团队，将工业化的know-how更好的整合到生产的知识体系

Serve as a bridge to connect floor and industrialization team, we aim to better integrate the know-how from indus team into the production knowledge system

• 负责生产层级的工艺变更、偏差和投诉

Complete change control, quality event, and complaints from technical at the production level

• 负责维护和更新批记录和pFMEA等工艺文件，具备生产侧变更风险评估的能力

Be responsible for maintaining and updating manufacturing procedures and process documents such as pFMEA, and be capable for change control RFR of change control from production

• 支持现场运营，制作和维护灌装和包装的标准样品

Support floor routine operation, fabricate and maintain functional test kits/samples for filling and packaging line

• 执行周期性工艺验证，包括清洁验证和设备验证等

Perform periodic process validation, including cleaning validation and process validation, etc

• 支持主管，专家和工程师参与突破性改善项目

Support supervisors, SME, and engineers to participate in breakthrough improvement projects

自身安全要求 Safety:

• 确保日常工作严格遵守HSE的政策和程序；

Ensure strict compliance with established HSE policies/procedures within daily operations.

• 在管理职责范围，贯彻执行国家、政府职能部门、地方的HSE相关法律法规要求，执行国家、地方、行业的HSE标准，履行法定的HSE管理义务并承担相应的职责，确保所辖部门全员遵守HSE法定义务和责任；

Within the scope of management responsibilities, follow the HSE-related laws and regulations of the country，government functional departments as well as local governments; Implement national, local, and industrial HSE standards; Perform statutory HSE management obligations and take corresponding responsibilities to ensure that all employees follow HSE legal obligations and responsibilities;

• 在管理职责范围，依照公司HSE管理体系要求开展HSE管理活动，建立并监督执行年度HSE工作、活动，在职责范围内对公司的年度HSE指标目标的完成情况负责。确保所辖部门全员遵守和执行公司的HSE管理要求和规定。

Within the scope of management responsibilities, carry out HSE management activities in accordance with the HSE management system requirements, establish and supervise the implementation of annual HSE work and activities, and be responsible for the completion of annual HSE goals. Ensure that all employees in the departments follow HSE management requirements and regulations.

• 学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。

Learn, master and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.

• 严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。

Strictly comply with HSE rules and regulations, and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely.

自身质量要求 Quality:

• 确保严格遵守QA/生产的程序、批记录和要求，确保完成角色所需的必须培训，如更衣、工业化SOP、工程SOP和质量SOP等；

Ensure strict compliance with established Production/QA procedures, ticket and requirements. Ensure individual are trained appropriately with procedures, such as gowning, Indus SOP, ENG SOP and Quality SOP etc.

• 确保自己始终遵循良好的文件书写习惯，起好模范带头作用；

Assure that Good Documentation Practices are always followed.

• 及时汇报所发现的质量问题，根据质量调查承接相应改善任务。

Report quality observation timely and take ownership on correction and CAPA according to investigation for responsible area.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

• 具有3年以上制药或医疗器械工厂相关经验，熟悉GMP或ISO13485；

More than 3 years Pharmaceutical or IVD Manufacturing Experience, be familiar with GMP/ISO13485.

• 较强的执行力和推进力；

Strong execution and propulsion.

• 较强的人际交往能力来进行跨部门和操作员的沟通；

Strong interpersonal skill to communicate with cross-functional team and operators.

• 熟悉电脑操作，善于使用MS Office，有文件管理系统, SAP, Trackwise等使用经验为佳；

Be familiar with PC operating, master MS Office, Doc mgt system, SAP/Trackwise/Traksys are plus.