Senior Maintenance Engineer

Category:  Manufacturing
Location: 

Tianjin, Tianjin, CN

   

Key areas of responsibility 主要工作职责:

Senior maintenance engineer is responsible for compliance of daily system running and maintenance activities that to ensure quality and efficiency of production. Work according to cGMP, GMP, GDP and SOP. Ensure NC, CR, QAP, validation, etc. are accomplished within schedule. Drive process improvement and standardization.

高级维护工程师的职责是保证日常设备系统运行和维护活动合规,保证生产高质、高效。遵循cGMP GMPGDPSOP执行工作,确保NCCRQAP、验证等工作按计划完成。推动工艺改进和标准化。

Drive innovation and process improvement for Production support systems FMS & BMS etc. by using new technology and automation improvement

支持各个自动化系统的稳定性运行以及利用新技术对系统进行优化。

Drive manufacture intelligence and predictive maintenance for system and equipment in production support area.

支持智能制造及前瞻性维护对暖通系统及其他生产支持系统。

The senior maintenance engineer position is responsible for design for the HVAC/FMS/BMS system for new filling plant. the position holder have advanced FMS/BMS knowledge so that to support deliver the system design fulfil the GMP/regulation requirement.  From design point of view to ensure system stable running with lower energy consumption and less maintenance cost.

高级维护工程师负责对暖通系统,FMS,BMS (时时监控/控制系统)的设计。具备暖通系统,FMSBMS系统的最新知识用以支持系统的设计符合GMP/法规的规定。从设计方面支持系统的稳定运行以及低能耗运行。

 

Main Job Tasks 主要工作任务:      

  • Development and execution HVAC system process optimization and standardization following cLEAN thinking according to the requirements of site business needs and site strategy.                                     根据公司业务需求和战略目标,遵循精益生产理念,正确发展和执行采暖通风空调系统的过程优化和标准化。

 

  • Manage and drive compliance and quality improvements of HVAC system to meet the cGMP requirements and global compliance project management, high qualified competence in the handling process of audit and inspection.                                                                                                  管理和推动采暖通风空调系统的合规和质量改进,满足cGMP和诺和诺德内部合规项目管理的需求,完全胜任内审和外审等审计过程。

 

  • Actively initiate continued improved HVAC system to meet the requirement of system stable, safe and high-efficiency running; cause analysis and PM/CM action setting up by Lean thinking and tools.                 主动实施采暖通风空调系统的持续改进以保证系统稳定、安全、高效地运行。将精益生产的理念和工具应用到预防性维护、日常维修以及故障根本原因分析中。

 

  • Development and implementation of system reliability/energy saving improvement projects and have the competence in CR/NC handling during daily operation and maintenance.                                    发展和实施有关系统稳定运行和节能运行的项目,并且具备处理项目改进以及日常运行维护中的CR/NC的能力。

 

  • Technical support of different engineering disciplines in project upgrade. Have right competence in external vendor management, minor projects management, validation process and GMP compliance.                 在系统项目改进过程中给予技术支持;对外部供应商及内部改进项目实施管理;具备系统验证能力和GMP合规性管理能力。

 

  • Actively involve all learning and sharing activities of Global Process group to ensure compliant to NN process requirement and take ownership to initiate the activities of area coaching and sharing.                      积极参与诺和诺德工艺负责组的所有活动,并进行积极分享和主动学习,确保天津工厂的采暖通风空调系统与全球的要求高度合规,并且积极实施部门内部的培训和分享活动。

 

  • Participate in validation, technology transfer and process improvements including:                          参与验证活动、技术转移和工艺改进:
    • Ensure validation and verification of processes, machines and equipment.                          确保对工艺流程、机器设备的检查和验证的实施
    • Responsible for event response and NC handling during validation.                                 解决验证期间发现的问题和不符合事件
    • Review and approve validation documentation and share best practice for validation with relevant stakeholders.                                                                                      审核并批准验证文件,分享最佳实践方法
    • Escalate problem according to escalation procedure.                                               按照流程上报问题
  • Manage and drive compliance and quality improvements of utility system to meet the cGMP requirements and global compliance project managementhigh qualified competence in the handling process of audit and inspection

管理和驱动公用工程系统的合规和质量改进满足cGMP和诺和诺德内部合规项目管理的需求,完全胜任内审和外审等审计过程

  • Actively involve all learning and sharing activities of Global FMS/BMS group to ensure compliant to NN/lates regulation requirement and take ownership to initiate the activities of area coaching and sharing

积极参与诺和诺德工艺负责组的所有活动,并进行积极分享和主动学习,确保天津工厂的公用工程设施系统与全球和最新法规要求高度合规,并且积极实施部门内部的培训和分享活动

  • Utilize the strong design capability to do the system optimization on utility systems including HVAC/FMS/BMS.

利用强大的设计能力,对包括暖通、FMS/BMS在内的公用事业系统进行系统优化。

  • Use big data analysis technology and other relevant new technologies to facilitate the Circular for Zero on water, energy and cost saving. 

利用大数据分析技术和其他相关新技术,促进"零循环"经济,增强对水、能源和成本的节约。

 

 

Education Background: 教育背景

 

  • Bachelor or Master Degree, major in HVAC engineering, mechanical and automation engineering, electrical or similar field. 采暖通风和空调工程,机械工程、自动化工程、电气工程或相关学科大学本科毕业或以上学历
  • Fluent in written and reading English.             流利的英语听说技能。

 

 

Professional Experience专业经验:

 

  • Minim 5-7 years of manufacturing working experience in pharmaceutical industry or in life science industry.   至少5-7年制药相关行业生产制造工作经验。
  • Minim 5 years engineering experience in maintenance of HVAC system, design, smoothly running, process improvement, and root cause analysis.                 至少5年采暖通风和空调系统及相关控制系统设计、维护、稳定运行、工艺改进以及故障根本原因分析等技术的工程类经验。
  • Have the knowledge of HVAC for clean area, process improvement methodologies, root cause analysis, reliability centered maintenance, pharmaceutical utilities.                                               具备无菌公用工程采暖通风和空调系统相关的工艺改进方法论知识、故障根本原因分析能力、系统可靠性维护经验和制药公用设施知识。
  • Have the knowledge of Part 11 & GMP standards, experience within cGMP, ISO9000, ISO14000.         具有cGMPGMPISO9000ISO14000标准的知识和经验。 
  • Proven expertise in planning/organization/execution of maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams.                     具备专业的计划、组织、实施维修活动的经验,跟踪活动结果,能够根据跨部门解决复杂问题的需要修改工作计划。
  • Automation Knowledge in the following systems:  Mechanical, Pharmaceutical Utilities, HVAC, electricity and relevant FMS&BMS system is preferred

具备机械工程,制药公用工程,空调系统,电气系统以及制药环境监控系统和楼宇自控系统等相关自动化工程知识背景优先。

  • Proven expertise in execution of operation& maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams on time

具备实际运行和维护专门知识技能,并且具有应急复杂问题分析处理能力以及跨部门协作沟通解决问题能力。

Be familiar with qualification requirement for

 

  • Automation/IT system.  Have the experience of automation processes/IT compliance validation is preferred

熟悉自动化系统及IT系统验证要求。具备对于自动化系统及IT 系统的验证经验

  • Have the experience with manufacture intelligence is preferred

具备智能制造理念及相关经验

  • Have the competency and knowledge of using big data and AI to support manufacture intelligence or predictive maintenance

具备运用大数据及人工智能推动智能制造及设备前瞻性维护的能力

  • In Depth knowledge on digital factory, support production support area to head to the digital utility in factory.
  • 深入了解数字工厂技术,支持引导生产支持部门进入数字化公用设施系统。
  • Have network with DFP or PS automation group or MIT group so share/learn good practice. Implement new tech which get inspiration from global IT or MIT,As well as drive cross function innovation improvement within DFP

与各DFP 工厂以及PS的自动化部门有充分协作与沟通,分享好的经验。推动新技术的运用并能够推动DFP 工厂之间新技术的运用。

  • Be familiar of equipment whole life cycle management process which support for the equipment lifecycle management and maintenance strategy define.
  • 熟悉设备全生命周期管理,支持合理的设备生命周期界定及维护策略的界定。

 

 

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
  • This position holder need to accept long term business trip aboard if required by project implement

这个岗位需要接受长期的国外出差的要求如果项目实施的需要。

 

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.