生产维修高级工程师

Brief Job Description 工作描述简述

Summarizes the job’s purpose or role and why it exists in the organization

概述工作的目的或角色及其在机构内的价值

Collaborate effectively with cross functions (GERE, global SME and stakeholders, external parties, etc) to support the high-quality and efficient deliverables of Formulation/Packing related projects, and contribute to build a smart, green factory to achieve autonomous manufacturing and zero carbon.

与跨部门团队（GERE、AZ各领域专家及外部合作方等）高效协作，支持无锡工厂制剂及包装相关项目的高质高效交付，助力实现自动化和零碳目标，打造智能绿色工厂。

Introduce new equipment, new process and new technology according to project strategy and plan, to deliver project on time.

按照项目策略计划支持新设备、新工艺、新技术引入，按时按质交付项目。

To comply SHE and GMP, through appropriate prevent maintenance plan-making, conducting maintenance activities effectively, quick response to trouble-shooting, make sure all the equipements in safe, high-yield manner.

在遵守安全、GMP的前提下，制定正确、有效的维护计划，高效实施维护活动，快速响应现场报修需求，确保所有生产设备处于安全和高效率的运行状态。

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

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. Familiarwith 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

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 authorisation and employment eligibility verification requirements.