Assistant Engineer, Production Maintenance

Under the premise of complying with safety and GMP creating correct and effective computerized system maintenance strategies and plans and efficiently implement system maintenance activities to ensure that the computerized system operates stably in a compliant environment and support the continuous and healthy progress of the business.

在遵守安全GMP的前提下制定正确和有效的计算机化系统维护策略和计划高效实施系统维护活动使得计算机化系统在合规环境下稳定运行支持业务持续良好地进行

Job Responsibilities

工作职责

Key Tasks

主要任务

Computerized System maintenance

计算机化系统维护

• Responsible for the establishment and optimization of computerized system maintenance strategies and processes.

负责计算机化系统维护策略及流程的建立和优化

• 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

• Lead or Support equipment Validation & Revalidation activity.

负责或支持设备验证或再验证

• audit work support as front person

作为前线人员提供审计工作支持

• Responsible the management in the user side for the system such as SAP/DH etc.

负责对SAP/DH等系统用户端的系统管理

• Responsible the OT automation network management.

负责 OT 自动化网络管理

Technical management

技术管理

• Check the GMP relative record regularly

定期检查GMP相关记录

• Computerized system risk assessment and management

计算机化系统风险评估和管理

• System integrity risk assessment

系统数据完整性评估

• Data Backup management

数据备份管理

• Data audit trail management

审计追踪数据管理

• Asset Management

资产管理

• Spare Parts Strategy

备品备件策略

Record and documentation

记录及文件

• Record all GMP activity promptly both in SAP and GMP related document.

在SAP及GMP相关系统中完整及时记录GMP活动信息

• Ensure the integrity and latest of system documentation

确保系统资料的完整性和最新版

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 system to get better performance with creative and effective solution

对系统的缺陷进行改造以使其更好的发挥性能

• Participate in new equipment introduction projects be responsible for equipment modification and improvement projects perform equipment-related matters according to the companys 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

Project management

项目管理

• Lead and manage projects to ensure that projects are completed on time and with high quality and to achieve PET strategic goals.

领导和管理项目确保项目按时按质完成达成部门的战略目标

• Proactively participate in and support digital project delivery within the team.

积极参与并支持团队内部的数字化项目交付

Training & knowledge sharing

培训与分享

• Standardize the training material for system operation

标准化系统操作培训材料

• Summarize skill and training engineer.

总结经验给与工程师培训

• Knowledge sharing with team member

与团队成员分享知识

Other responsibilities其他职责

• Ensures compliance to internal and external regulations policies principles

确保遵守内外部法规政策原则

• Ensure Compliance to current GMP SHE requirements.

确保遵守现行GMP安全等的规定

• Ensure alignment with company culture and maintain a healthy team atmosphere.

确保符合公司文化及维持健康的团队氛围

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 computer science and technology electrical automation engineering

计算机科学和技术或电气自动化专业本科或以上学历

• Qualification-资质

Maintenance on process control equipment computerized system automation control system.

维护过程控制设备计算机系统和自动化控制系统

• 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

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.