Production engineer 生产工程师
诺和诺德(中国)制药有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-07-15
- 工作地点:天津-滨海新区
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:8千-1.2万·13薪
- 职位类别:产品工艺/制程工程师
职位描述
Key areas of responsibility 主要工作职责:
The production engineer will have an end-to-end view of the Process. Will have a broad perspective. The production engineer is the key point of contact and coordination regarding improvements and solutions for the assembly process to build up the bridge between production and product specialist, process engineers and maintenance engineers. The production engineer is a shift arrangement anchored into production shift, close to production line see problem earlier, systematic problem solving and share in standardization. Timely respond all problems on the first line employees in all shifts.
The production engineer is responsible for driving process improvement of the assembly Process on site, and across process , maintenance ,components and product by utilising own network across the DD area. The production engineer is responsible for the following indicators of the process performance.
· Implement and upgrade 168703
· Usage and Usability and creation and update of Standards linked with product and production process
· Technical support from product knowledge and production process on first line employees
· Driving product problem identification earlier and take preventive actions
· Driving continuous improvement
· Driving complicated problem solving process (A3)
· Specialize in statistic tool, standardize statistic tools box in DD
· Driving increase in productivity by elimination of complexity in compliance
生产工程师总览器械组装生产的工艺流程,进行端到端的检查。作为组装工艺改进和解决方案的关键负责人,与产品专家、工艺及维修工程师沟通协调。生产工程师跟随倒班生产,贴近生产线以便于及时识别问题,系统行解决问题并分享标准化解决方案。对生产一线反汇报的异常做及时的现场响应。
生产工程师负责推动生产流程的改进,协调部门工艺、维修、组件及产品负责人以协助部门达成工作目标。生产工程师负责推进以下业绩指标:
o 执行和升级168703
o 产品和生产流程标准的建立、更新、可用性以及使用情况
o 对一线员工提共相关的产品知识以及生产流程的技术支持
o 推动产品问题的提早识别并正确实施预防措施
o 推动持续改进
o 领导复杂问题解决流程(A3)
o 研究并统一统计和方法工具
o 通过在合规范围内去除复杂流程实现生产力提高
Main Job Tasks 主要工作任务:
· Take the responsibility to implement all work content of SOP168703 in shift production period and continue improvement of SOP168703 with the product specialist for better utilisation
在倒班生产过程中,负责执行SOP168703的所有内容并与产品专家一起持续改进和升级便于更好的使用。
· Act as product technical responsible for NovoPen assembly area in shift production period.
在倒班生产过程中,担任天津工厂诺和笔组装过程的产品技术负责人。
· Act as product monitoring responsible person for DD key production process: Continuously monitors and analyses input sources to identify quality problems. 担任耐用器械关键生产过程的产品责任人: 持续监督和分析,发现质量问题。
· Acts as a product advocate of production process, coordinating daily schedule with all process stakeholders from production Supervisors to Managers and process engineer, maintenance engineer and product specialist. Engage in optimizations throughout and on and removing barriers and enabling the process to run optimally.
作为生产过程的产品负责人,在日常工作中协调各个相关方如生产主管、经理、工艺工程师、维修工程师、产品专家等,排除障碍,确保工艺最优化运行。
· Through deep process understating team work with component engineer, process engineer ,maintenance engineer to build up a good view to improve quality, reduce variation and get the cost saving.
通过对工艺过程的深入理解, 与组件工程师,工艺工程师,维修工程师合作,提高生产产品质量、减少变动、降低成本。
· Real time Coaching/mentoring of Operators, technicians and supervisors from the technical aspects within:
在日常生产操作过程中从技术层面实时指导操作工、技术员和主管:
o Execution of all activities of SOP168703
执行SOP168703的全部内容
o Take preventive actions on potential quality risks of product
针对产品质量的潜在风险实施预防性措施
o A3 and 3C and structured Problem solving
执行A3、3C以及系统化地解决问题
o Execution LEAN KATA thinking and KATA experiment practice
践行LEAN KATA的思维并且执行KATA试验
· Execute process confirmation of all operation Standards and work with relevant process and technical teams to find ideas to proactively improve quality and compliance. 通过对所有生产SOP执行过程确认找到前瞻性地改进质量和合规性的方法。
· Collaborate Across boundaries, share experiences and engage within DD area, as well as escalating issues.
与DD 内部成品生产横向合作,分享经验,上报问题。
· Ensure support of process improvement projects in local site project portfolio and timely progress of these projects.
负责对DD 区域内的工艺改进项目提供技术支持并确认执行情况
· Based on analysis, data and strategy understanding the production engineer need support the improvement by creating relevant business cases. 基于分析报告、数据和战略性理解,建立相关业务案例,支持改进项目的推进
· Responsible for continuously improving the framework for gathering process data and give direction for how to analyse those data and prioritise initiatives based on the analyses. 持续改进,收集、分析数据,基于数据分析确定工作优先顺序。
· Ensuring daily support to production units and support units within the process including that efficient KPIs are developed and followed up on, standards are followed and improved, training is being executed as needed, process confirming on all relevant activities is being done.
保证对日常生产的工艺支持,包括:建立高效的KPI指标并跟踪执行,改进并跟进标准执行,提供培训,实施过程确认。
· The production engineer is the main responsible for presenting on shopfloor, and for ensuring compliance to production process in case of the maintenance handover and project handover.
生产工程师作为现场生产过程支持的首要负责人在维修移交以及项目移交过程中确保过程合规并无质量风险。
· Support to the statistical calculation and analysis on the production and validation: 支持生产和验证的统计计算和分析:
o Support to deviation investigation of production relevant, including the MSA, DoE, Sampling etc.
支持生产相关的偏差调查:MSA,DOE,取样等
o Support to validation, including test plans, calculation, report etc. meet the triangle of QCD.
支持验证工作:测试计划,计算,报告等并确保整个过程满足质量、费用和交付的综合要求。
· Coaching on compliance and train first line employees on process knowledge: 指导和培训一线员工工艺知识:
o Identify compliance gaps in responsible process
识别合规风险
o Coach first line employees and supervisors on compliance
指导一线员工以及主管的合规工作
o Share findings and new regulation requirements
分享审计发现点和新要求
o Follow up PI/QI/DI of production relevant and ensure occurrence happen in SPS
跟踪生产相关的PI/QI/DI,并通过系统的方式预防一线员工的操作原因导致的犯错
· Inputs on DV/CR and process improvement:
针对工艺改进和DV/CR给出意见:
o Review DV/CR
检查DV/CR
o Provide professional idea to continuous improvement projects.
在改进项目中给出专业意见
o Share best practice.
分享***实践方法
Professional Experience专业经验
· Minim 5 years of manufacturing working experience in a pharmaceutical environment. 至少5年相关工作经验。
· In depth knowledge of Durable Device Products and production process. 丰富的耐用器械产品和生产流程的知识。
· Experience using lean/six sigma methodologies and LEAN KATA philosophy achieving sustainable process improvement.
具有运用精益生产管理方法(精益套路以及六西格玛等)持续改进工艺的经验
· Understands business needs and able to integrate specialist knowledge and business perspective.
充分理解业务需求,具有将业务需求与专业知识相结合的能力。
Education Background: 教育背景
· Bachelor or master’s degree in manufacturing engineering, pharmacy, chemistry 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 and relevant working experiences of GMP regulation, validation, LEAN and statistics etc.
· 接受过GMP、验证、精益管理、统计等的培训并具有相关的工作经验
· Project management training is preferable. ***接受过项目管理培训。
· Fluent in written and reading English. 流利的英语听说技能。
The production engineer will have an end-to-end view of the Process. Will have a broad perspective. The production engineer is the key point of contact and coordination regarding improvements and solutions for the assembly process to build up the bridge between production and product specialist, process engineers and maintenance engineers. The production engineer is a shift arrangement anchored into production shift, close to production line see problem earlier, systematic problem solving and share in standardization. Timely respond all problems on the first line employees in all shifts.
The production engineer is responsible for driving process improvement of the assembly Process on site, and across process , maintenance ,components and product by utilising own network across the DD area. The production engineer is responsible for the following indicators of the process performance.
· Implement and upgrade 168703
· Usage and Usability and creation and update of Standards linked with product and production process
· Technical support from product knowledge and production process on first line employees
· Driving product problem identification earlier and take preventive actions
· Driving continuous improvement
· Driving complicated problem solving process (A3)
· Specialize in statistic tool, standardize statistic tools box in DD
· Driving increase in productivity by elimination of complexity in compliance
生产工程师总览器械组装生产的工艺流程,进行端到端的检查。作为组装工艺改进和解决方案的关键负责人,与产品专家、工艺及维修工程师沟通协调。生产工程师跟随倒班生产,贴近生产线以便于及时识别问题,系统行解决问题并分享标准化解决方案。对生产一线反汇报的异常做及时的现场响应。
生产工程师负责推动生产流程的改进,协调部门工艺、维修、组件及产品负责人以协助部门达成工作目标。生产工程师负责推进以下业绩指标:
o 执行和升级168703
o 产品和生产流程标准的建立、更新、可用性以及使用情况
o 对一线员工提共相关的产品知识以及生产流程的技术支持
o 推动产品问题的提早识别并正确实施预防措施
o 推动持续改进
o 领导复杂问题解决流程(A3)
o 研究并统一统计和方法工具
o 通过在合规范围内去除复杂流程实现生产力提高
Main Job Tasks 主要工作任务:
· Take the responsibility to implement all work content of SOP168703 in shift production period and continue improvement of SOP168703 with the product specialist for better utilisation
在倒班生产过程中,负责执行SOP168703的所有内容并与产品专家一起持续改进和升级便于更好的使用。
· Act as product technical responsible for NovoPen assembly area in shift production period.
在倒班生产过程中,担任天津工厂诺和笔组装过程的产品技术负责人。
· Act as product monitoring responsible person for DD key production process: Continuously monitors and analyses input sources to identify quality problems. 担任耐用器械关键生产过程的产品责任人: 持续监督和分析,发现质量问题。
· Acts as a product advocate of production process, coordinating daily schedule with all process stakeholders from production Supervisors to Managers and process engineer, maintenance engineer and product specialist. Engage in optimizations throughout and on and removing barriers and enabling the process to run optimally.
作为生产过程的产品负责人,在日常工作中协调各个相关方如生产主管、经理、工艺工程师、维修工程师、产品专家等,排除障碍,确保工艺最优化运行。
· Through deep process understating team work with component engineer, process engineer ,maintenance engineer to build up a good view to improve quality, reduce variation and get the cost saving.
通过对工艺过程的深入理解, 与组件工程师,工艺工程师,维修工程师合作,提高生产产品质量、减少变动、降低成本。
· Real time Coaching/mentoring of Operators, technicians and supervisors from the technical aspects within:
在日常生产操作过程中从技术层面实时指导操作工、技术员和主管:
o Execution of all activities of SOP168703
执行SOP168703的全部内容
o Take preventive actions on potential quality risks of product
针对产品质量的潜在风险实施预防性措施
o A3 and 3C and structured Problem solving
执行A3、3C以及系统化地解决问题
o Execution LEAN KATA thinking and KATA experiment practice
践行LEAN KATA的思维并且执行KATA试验
· Execute process confirmation of all operation Standards and work with relevant process and technical teams to find ideas to proactively improve quality and compliance. 通过对所有生产SOP执行过程确认找到前瞻性地改进质量和合规性的方法。
· Collaborate Across boundaries, share experiences and engage within DD area, as well as escalating issues.
与DD 内部成品生产横向合作,分享经验,上报问题。
· Ensure support of process improvement projects in local site project portfolio and timely progress of these projects.
负责对DD 区域内的工艺改进项目提供技术支持并确认执行情况
· Based on analysis, data and strategy understanding the production engineer need support the improvement by creating relevant business cases. 基于分析报告、数据和战略性理解,建立相关业务案例,支持改进项目的推进
· Responsible for continuously improving the framework for gathering process data and give direction for how to analyse those data and prioritise initiatives based on the analyses. 持续改进,收集、分析数据,基于数据分析确定工作优先顺序。
· Ensuring daily support to production units and support units within the process including that efficient KPIs are developed and followed up on, standards are followed and improved, training is being executed as needed, process confirming on all relevant activities is being done.
保证对日常生产的工艺支持,包括:建立高效的KPI指标并跟踪执行,改进并跟进标准执行,提供培训,实施过程确认。
· The production engineer is the main responsible for presenting on shopfloor, and for ensuring compliance to production process in case of the maintenance handover and project handover.
生产工程师作为现场生产过程支持的首要负责人在维修移交以及项目移交过程中确保过程合规并无质量风险。
· Support to the statistical calculation and analysis on the production and validation: 支持生产和验证的统计计算和分析:
o Support to deviation investigation of production relevant, including the MSA, DoE, Sampling etc.
支持生产相关的偏差调查:MSA,DOE,取样等
o Support to validation, including test plans, calculation, report etc. meet the triangle of QCD.
支持验证工作:测试计划,计算,报告等并确保整个过程满足质量、费用和交付的综合要求。
· Coaching on compliance and train first line employees on process knowledge: 指导和培训一线员工工艺知识:
o Identify compliance gaps in responsible process
识别合规风险
o Coach first line employees and supervisors on compliance
指导一线员工以及主管的合规工作
o Share findings and new regulation requirements
分享审计发现点和新要求
o Follow up PI/QI/DI of production relevant and ensure occurrence happen in SPS
跟踪生产相关的PI/QI/DI,并通过系统的方式预防一线员工的操作原因导致的犯错
· Inputs on DV/CR and process improvement:
针对工艺改进和DV/CR给出意见:
o Review DV/CR
检查DV/CR
o Provide professional idea to continuous improvement projects.
在改进项目中给出专业意见
o Share best practice.
分享***实践方法
Professional Experience专业经验
· Minim 5 years of manufacturing working experience in a pharmaceutical environment. 至少5年相关工作经验。
· In depth knowledge of Durable Device Products and production process. 丰富的耐用器械产品和生产流程的知识。
· Experience using lean/six sigma methodologies and LEAN KATA philosophy achieving sustainable process improvement.
具有运用精益生产管理方法(精益套路以及六西格玛等)持续改进工艺的经验
· Understands business needs and able to integrate specialist knowledge and business perspective.
充分理解业务需求,具有将业务需求与专业知识相结合的能力。
Education Background: 教育背景
· Bachelor or master’s degree in manufacturing engineering, pharmacy, chemistry 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 and relevant working experiences of GMP regulation, validation, LEAN and statistics etc.
· 接受过GMP、验证、精益管理、统计等的培训并具有相关的工作经验
· Project management training is preferable. ***接受过项目管理培训。
· Fluent in written and reading English. 流利的英语听说技能。
职能类别:产品工艺/制程工程师
公司介绍
诺和诺德在中国
诺和诺德是中国市场的领导者,一直以改变为己任。诺和诺德(中国)制药有限公司于1994年成立,二十几年来业务一直保持强劲增长。公司总部设在北京,产品和服务遍及全国所有省、直辖市及中国港澳台地区。截至2017年底,诺和诺德在华员工总数4329人。诺和诺德是在中国建立研发中心的生物制药公司。位于北京的研发中心是诺和诺德全球研发体系的组成部分,致力于与总部合作研发新产品及新生产工艺。诺和诺德在中国的生产厂位于天津,是公司的国际化战略生产基地。公司对工厂提供了大量的资金投入和技术支持,向全球以及中国市场供应产品。诺和诺德在中国的不断发展反映了公司对中国市场的承诺。
Novo Nordisk in China
As the leader in the Chinese market, Novo Nordisk has always been committed to Changing.
Founded in 1994 and headquartered in Beijing, Novo Nordisk’s presence in China has been growing for more than 20 years.Headquartered in Beijing, providing products and services across mainland China as well as Hong Kong, Macau and Taiwan of China. As of the end of 2017, Novo Nordisk employed over 4,329 employees in China.
诺和诺德是中国市场的领导者,一直以改变为己任。诺和诺德(中国)制药有限公司于1994年成立,二十几年来业务一直保持强劲增长。公司总部设在北京,产品和服务遍及全国所有省、直辖市及中国港澳台地区。截至2017年底,诺和诺德在华员工总数4329人。诺和诺德是在中国建立研发中心的生物制药公司。位于北京的研发中心是诺和诺德全球研发体系的组成部分,致力于与总部合作研发新产品及新生产工艺。诺和诺德在中国的生产厂位于天津,是公司的国际化战略生产基地。公司对工厂提供了大量的资金投入和技术支持,向全球以及中国市场供应产品。诺和诺德在中国的不断发展反映了公司对中国市场的承诺。
Novo Nordisk in China
As the leader in the Chinese market, Novo Nordisk has always been committed to Changing.
Founded in 1994 and headquartered in Beijing, Novo Nordisk’s presence in China has been growing for more than 20 years.Headquartered in Beijing, providing products and services across mainland China as well as Hong Kong, Macau and Taiwan of China. As of the end of 2017, Novo Nordisk employed over 4,329 employees in China.
联系方式
- Email:xrnj@novonordisk.com
- 公司地址:北京市朝阳区广顺南大街8号利星行中心3号楼4,5层 (邮编:100102)
- 电话:18701492989