Process Engineer

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

• Bachelor Degree and above in manufacturing engineering or similar education background.     制造工程或相关学科领域大学本科及以上学历。
• Education/training of GMP regulation, validation, LEAN and statistics is preferable.                    最好接受过GMP、验证、精益管理、统计的培训。
• Fluent in written and reading English.                流利的英语听说技能。

Professional Experience专业经验:

• Minim 4-6 years of relevant working experience.           至少4-6年相关工作经验。
• Experience in automation and mechanical areas.           机械、自动化领工作经验。
• Experience of working in a production environment with highly automated machines.                              在高度自动化设备生产环境的工作经验。
• Experience of GMP/ISO 9001/ISO 13485 regulated production, validation and change procedures.             GMP、ISO9001、ISO13485标准化要求的生产、验证、变更管理流程的工作经验。

Job content工作内容描述

Key areas of responsibility 主要工作职责:

Process engineer is responsible for compliance of daily production activities that to ensure quality and efficiency of production. Work according to GMP, GDP and SOP. Ensure NC, CR, PSE, QAP, validation, etc. are accomplished within schedule, and OEE, scrape rate are meet the KPI. 

工艺工程师的职责是保证日常生产活动合规，保证生产高质、高效。遵循GMP、GDP和SOP执行工作，确保NC、CR、PSE、QAP、验证等工作按计划完成；确保OEE、废品率等KPI指标达标。

Main Job Tasks 主要工作任务:      

• Be the owner of appointed production machine/equipment.                                                  担当指定生产设备的负责人。

• All actions with deadline should be finished on time, that include QAP, NC, NC3, CR, CR6, PSE, VSS, etc.     按时完成QAP、NC、NC3、CR、CR6、PSE、VSS等工作任务。

• Set up metrology specification and insure calibration meet MPE requirement. Execute machine software backup verification, machine test relevant to investigation or validation.                                     建立测量说明书并校准设备，以确保符合最大允许误差的要求。执行验证相关设备软件备份检查和设备测试。

• Execute process validation when machine rebuilding happened.                                             设备重建时进行验证。

• Periodically review logbook according to requirement.                                                       按照规定定期检查日志文件。

• Update and archive all relevant documentation within in deadline after validation is finished.                 验证完成之后，在规定的时间内完成相关文件更新和存档。

• Execute machine improvement when machine have down time, high scrap rate occur, and quality issue in the long time run.　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　      当发生设备停机、废品率升高、长期存在质量问题时，进行设备改进工作。

• As process owner is responsible for handling compliance issue and all kinds of audits as well as relevant findings action.                                                                                             处理合规问题和应对审计，对所有发现点采取行动。

• Use SPS problem solving method for troubleshooting.                                                       运用系统解决问题的方法解决问题。

• Handle all reported quality incidents and close them on time.                                               按时处理并解决质量事件。                                          

• Daily monitor product scrap rate and making relevant action plan. 　                                       监控产品废品率并采取相关行动。

Other individual assignments 其他工作任务:

• Incorporate Novo Nordisk Way (NNW) into daily way of working                                             将诺和诺德之道（NNW）融入到日常工作中
• Other work assigned by line manager.                                                                       直线经理安排的其他工作。
• Keep line manager accurately informed of work status as well as any problems                              保证将工作状态和所有问题准确通知到直线经理