Professional Experience专业经验:
• Minim 5 years of experience in pharmaceutical manufacturing with GxP regulation.
至少5年制药加工行业相关工作经验，熟悉GxP规范。
• Engineering experience in water treatment systems (covered purified water, water for injection and clean steam etc.) design, maintenance, operation, process improvement and root cause analysis.
具备水处理（涵盖纯水、注射水以及洁净蒸汽等）相关的设计、运行、维护、工艺改进以及故障根本原因分析等技术工程类经 验。
• Proven expertise in execution of validation and GMP relevant documentation (NC/CR/QAP) etc. Following up on the process and relevant stakeholder and revising the work plan for complex problems being resolved by cross functional teams on time.
具备验证和GMP相关文件等的处理能力，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。
• Have knowledge in the following systems: mechanical,pharmaceutical utility, process design and project management etc.
具有机械工程、制药公用工程、系统设计和项目管理等的专业知识背景。
• Experience of project management is preferable.
最好有项目管理经验
• Experience of instrument is preferable.
最好有仪表经验

Key areas of responsibility 主要工作职责:
CU engineer is responsible for compliance of daily system running and maintenance activities that to ensure stable and high quality deliveries of water, steam and process air for AP production. Work according to cGMP, GMP, GDP and SOP. Ensure NC, CR, QAP, validation, etc. are accomplished within schedule. Drive process improvement and standardization.
CU工程师的职责是保证日常设备系统运行和维护活动合规，确保为无菌生产供应稳定并且高质量的水、蒸汽、空气。遵循cGMP 、GMP、GDP和SOP执行工作，确保NC、CR、QAP、验证等工作按计划完成。推动工艺改进和标准化。

Main Job Tasks 主要工作任务:
• New Clean Utility System Design 洁净设施设备系统设计：
o Participate in supplier evaluations to ensure that selected suppliers meet NN requirements.
参与供应商的评估，确保供应商能满足NN的要求。
o Participant in project management to ensure assignments in compliance with agreed time schedule, budget and quality requirements.
参与项目管理，确保任务的完成符合预定计划，预算及质量要求。
o Review the documents provided by the design institute, give opinions according to the requirements of URS, ES, and complete the signing of design drawings/document with the design institute.
审核设计院提交的文件，并根据URS, ES的要求给出意见，并和设计院一起完成设计图纸/文件的签署。
o Participate in CU design review meetings for risk assessment, joint design institute, QA, and OR/ER approvals.
参与CU部份的design review meeting进行风险评估，联合设计院，QA，以及OR/ER批准。
o Responsible for the URS, ES of the CU system, involve HQ and QA to review, approve the URS, ES, and work with the design institute to make sure the design complies with URS, ES.
负责URS，ES，与总部及QA复核， 批准URS和ES，并和设计院一起将URS，ES落实到设计当中。
• On-site construction and installation 现场施工和安装
o Participate in supplier/vendor/TPR supervision or management to ensure that they perform their work by strictly following the procedures and standards of NN and the deliverables from them meet NN requirements.
参与供应商/厂家/第三方的监管，确保他们在严格遵守诺和诺德流程和标准的前提下实施工作且他们的交付物能满足NN的要求。
o Participate in equipment selection, FAT and SAT of CU to ensure the smooth installation and commissioning of CU systems.
参与设备选型，FAT以及SAT，确保CU系统的顺利安装及调试。
• On-site adjustment and installation 现场调试和验证
o Support and coordinate within work package and external stake folders to ensure delivering effective solutions, interface management and validation dependencies.
参与工作包内的协调及与部门外部的协调工作，确保交付有效的解决方案，交界面管理和验证顺序。
o Prepare, review, and involve QA to approve the clean utility systems validation plan and validation report to ensure that the validation of the clean utility meets SRV requirements, cGMP and local standards.
准备，复核，并involve QA 批准clean utility系统的验证计划和验证报告，确保clean utility的验证满足SRV要求，cGMP法规及中国法规的要求。
o Participate in the verification of the clean utility system, ensure that the clean utility system can meet the needs of URS, handle engineering changes and verification deviations in the verificationprocess according to NN requirements, establish a baseline after the completion of the verification, and ensure that the CU system is released to the user on time.
参与CU系统验证，确保CU系统能满足URS的需求，按NN要求处理验证过程中出现的工程变更以及验证偏差，在验证结束后建立基准，并确保CU系统按时放行给用户。
• Daily maintenance and operation
o Participated and support to establish of new plant high level project management documentation establishment, such as PQMP, VPL, IAR, etc.
参与协助建立新建厂高级别项目管理文件，如PQMP，VPL，IAR等。
o Participant in setup the system periodic evaluation of the CU system, handle CR and DV during operation according to NN procedure.
参与建立洁净公共设施系统的系统周期性评估，根据NN要求实施运行过程中的变更及偏差处理
o Handle temporary system failures, and use SPS methods to analyse the root causes, and take corrective and preventive measures accordingly.
处理临时系统故障，并利用SPS的办法进行原因分析，并采取相应的纠偏以及预防措施。
o Develop quality mindset in the area to ensure compliance with legal or regulatory requirements and NN quality system including policies and safety rules.
在部门内发展质量意识，确保诺和诺德质量体系内及法律法规范围内的合规性，包括政策合规和安全规定的合规。
o Drive or participate in event response activities on own site using systematic problem solving, establishing cause and effect relationships that determine root cause. Leverage solutions, best practices and benefits to PG group through business cases according to MSP.
推动或参与事件响应活动，用系统解决问题的方法寻找问题根本原因。按照MSP的要求通过实际业务案例向工艺负责组说明解决方案、实践方法和益处。
o Ensure anchoring of process improvement projects in local site project portfolio.
关注工艺改进项目。
o Share and prioritise solutions and improvement projects. Evaluate and implement process solutions and better practices locally and across DFP according to MSP.
按照MSP的要求分享改进项目，确定解决方案的优先次序，在天津工厂以至于DFP范围内评估并执行解决方案和实践。
o Participate in validation, technology transfer and process improvements including
参与验证活动、技术转移和工艺改进
o Escalate problem according to escalation procedure.
按照流程上报问题
o Ensure compliance to external and internal regulations.
确保合规

Education Background: 教育背景
• Bachelor Degree or above major in water treatment, chemical engineering, pharmaceutical or other relevant fields.
水处理、化工工程、制药工程或相关专业领域大学本科或以上学历。
• Excellent communication skill in written and spoken English.
熟练的英语听说读写技能。
• Professional training of cLEAN 2 star or an equivalence.
cLEAN2星或者同等培训经历。

其他信息

行业要求：全部行业