Sr. Engineer, Production Maintenance

Job Responsibilities
工作职责

Stream Management
业务模块管理

• Enable the stream deliverables to plan, incl., facility/process design, supplier selection, FAT, SAT, qualification, handover, etc.

确保相关业务模块成果按计划交付，包括厂房/工艺设计、供应商选择、FAT、SAT、确认、移交等。
• Work with all stakeholders to achieve the defined project targets.
积极与所有利益相关者合作，设计和交付项目目标。
• Support stream leader to ensure the project management under AZ PMF framework, incl., reporting, escalating, communication, change management, etc.
支持业务模块负责人确保AZ PMF框架下的项目管理，包括报告、升级、沟通、变更管理等。
• Conduct communications across functions o share the progress of the project execution.
跨部门进行沟通，分享项目实施的进展情况。
• Be as the production Maintenance representative to do the impact assessment for each change control via risk-based approach.
• 作为维修工程师，对每个变化在考虑风险的基础上进行影响性评估。

Production equipment maintenance
生产设备维护

• Carry out routine preventive maintenance plan by process and continuously improve equipment maintenance strategy.
按流程对设备定期进行预防性维护并持续完善设备维护策略
• Possesses the ability to maintain servers, PLCs, SCADA systems, HMIs, MES, and other related systems, and is familiar with communication protocols including Ethernet, TCP/IP, Modbus, Profibus, and OPC UA.
具备维护服务器、PLC、SCADA、人机界面、MES等系统维护的能力，熟悉以太网、TCP/IP、Modbus、Profibus、OPC UA等通讯协议。
• Engineering spare parts ordering and stock management to support production needs
及时定购设备备品备件，以满足生产的需求。
• Identify equipment fault and perform prompt and efficient repairing
及时解决生产中出现的设备故障
• Responsible for deviation investigation and report, implementation of corrective actions and preventive actions (CAPA)
负责偏差调查和报告，负责执行纠错措施和预防措施。
• Support equipment Validation & Revalidation activity.
支持设备验证或再验证
• Support audit work
支持各类审计工作

Technical management
技术管理

• Check the GMP relative record regularly
定期检查GMP相关记录。
• Equipment maintenance risk assessment and management
设备维修风险评估和管理。

Maintenance record and documentation
维护记录及文件

• Build the strategy and system of equipments maintenance, preparation
for drafting maintenance SOP and conducting training to maintenance
staff.
建立维护策略及体系及培训资料
• Fill and keep preventive maintenance and repairing records correspondingly and timely
准确及时填写设备维护，维修记录
• Record all maintenance activity promptly both in SAP and GMP related document.
在SAP及GMP相关系统中完整及时记录设备信息
• Keeping all equipment documentation and backup software updated with the function
确保设备资料以及备份软件的完整性

Equipment performance improvement & validation activity
设备改进及验证工作

• Drive CI activity and standardize the achievement.
驱动持续改善, 标准化成果。
• Modify any defectives of equipment to get better performance with creative and effective solution
对设备的缺陷进行改造以使其更好的发挥性能
• Suggestion for optimizing operation procedure
生产流程优化建议
• Participate in new equipment introduction projects, be responsible for equipment modification and improvement projects, perform equipment related matters according to the company's change process and verification process, and ultimately deliver qualified equipment.
参与新设备引入及负责设备改造改进项目，按公司变更流程和验证流程执行设备相关事务并最终交付合格设备。
• Complete the modification and introduction of equipment according to the process and be responsible for URS/DQ/IQOQ and other work.
按流程完成设备的改造和引进，负责URS/DQ/IQOQ等工作。

Training &knowledge sharing
培训与分享

• Prepare & provide training to operator so that the equipment can be able
to operated properly and safety
培训操作人员正确安全操作设备。
• Summarize skill and training technician.
总结经验，培训技术员。
• Established an effective internal system for sharing knowledge and experience, summarized lessons learned, and communicated them to team members.
团队内部建立有效的知识经验分享体系，总结经验与教训，与团队成员知识经验分享。

Other responsibility
其他职责

• Ensures compliance of self and others to internal and external
regulations, policies, principles
确保自己和他人遵守内外部法规,政策，原则。
• Ensure Compliance of self and others to current GMP, SHE requirements.
确保自己和他人遵守现行GMP，安全等的规定
• Ensure team are following company culture and team climate is heathy.
确保团队符合公司文化及打造健康的团队氛围。

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

Education, Qualifications, Experience
教育、资质、经验

• Academic/Professional qualification
学历/专业资格
Bachelor degree or above, major in
mechanical or electrical automation
engineering.
机械或电气自动化专业本科或以上学
历。
• Qualification-资质
Maintenance on process control equipment,
mechanical and electrical and pneumatics
system and components.
流程设备, 机械和电气和气动的系统和组
件的维护.
Pharma. formulation knowledge and
technical solutions.
医药制剂的知识和技术方案.
• Experience-经验
5 Years of working experience technical
related, 5年相关技术工作经历.
• Desirable-理 想
3 Years above MNC working experience
related to equipment maintenance. Familiar
with formulation equipment.
3 年以上的跨国企业设备维护相关工作
经验， 并熟悉制剂设备。
• Project management skill
项目管理的技能

Capabilities
能力

• GXP and quality management;
GXP 和质量管理；
• Finance evaluation and data analysis
capability
财务分析和数据分析能力
• Good lean mindset and basic lean
knowledge.
良好精益理念和基本的精益知识
• Good technical management and
communication internally or externally.
良好的技术管理以及内部外的沟通能
力。
• Familiar with business related
regulation/standard.
熟悉业务相关的法规标准。
• Master and apply appropriate lean and
project management tools, like PDCA, PPS
etc.
掌握并应用合适的精益和项目管理工
具，如PDCA, PPS 等等；
• Digital thinking capability
数字化思维能力

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.