Engineer, Production Maintenance
To comply SHE and GMP, through appropriate prevent maintenance plan-making, conducting
maintenance activities effectively, quick response to trouble-shooting, make sure all the equipments 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。
Typical
Accountabilities
主要职责
Production equipment maintenance
生产设备维护
• Carry out routine preventive maintenance planby 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
• 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
• 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
• Draft technique WI as required 如需要，起草相关工作指导
• Responsible for investigating equipment maintenance deviations, and implementing corrective actions and preventive actions (CAPA). 负责设备维修类偏差调查，并执行纠错措施和预防措施
• Support Equipment maintenance risk assessment and management 参与设备维修风险评估和管理
• 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
Equipment modification and improvement and introduction
设备改造改进和引进
• 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. 参与新设备引入项目，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，给与技工培训。
• Knowledge sharing with team member与团队成员分享知识。
Equipment operation(Sterile）
设备操作（针剂）
• Operate certain equipment in proper way when production batch happens when required.（such as FDs）需要时，在批生产过程中负责相关设备操作,如冻干机
• Be able to operate related machines within service function while maintaining and repairing 在维护或维修过程中，能运用设备服务功能。
Other responsibility
其他职责
• Ensures compliance of self to internal and external regulations, policies,
principles,.确保自己遵守内外部法规,政策，原则。
• Ensure Compliance of self to current GMP, SHE requirements.确保自
己遵守现行GMP，安全等的规定
• Well coordinate with group leader/PF/PCO members in daily operation:
日常工作中与带班/生产负责人/流程团队成员紧密协调
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.
