岗位职责：
1.负责ADC无菌药品生产设备（主要包括隔离器、灌装线、冻干机、包装线、清洗机、灭菌柜）的日常运行、维护和保养工作，确保设备运行稳定。制定并实施设备的预防性维护计划，定期检查设备状态，减少非计划停机时间。
Be responsible for the routine equipment maintenance of ADC production line equipment (including isolators, filling lines, lyophilizers, packaging lines, washers, and sterilizers/autoclaves, etc.), ensuring stable performance. Develop and implement preventive maintenance plans, conduct periodic condition checks, and reduce unplanned downtime.
2.对设备运行中的故障进行及时排查和修复，完成根本原因分析并制定预防措施。确保设备的清洁、润滑、零部件更换等维护工作符合GMP规范。
Troubleshoot and repair equipment faults in a timely manner; perform root cause analysis and implement preventive measures. Ensure maintenance activities—cleaning, lubrication, and parts replacement—comply with GMP requirements.
3.参与新设备的设计和验证工作（如DQ/IQ/OQ/PQ），确保设备符合工艺需求及GMP要求。支持新设备的选型、采购及验收，确保设备技术参数满足生产需求。配合工艺开发及技术转移工作，为设备调试及验证提供技术支持。
Participate in the design and qualification of new equipment (DQ/IQ/OQ/PQ) to ensure alignment with process needs and GMP. Support equipment selection, procurement, and acceptance, ensuring technical specifications meet production requirements. Collaborate with process development and technology transfer to provide technical support for commissioning and qualification.
4.负责机械维修团队的日常管理，包括人员排班、任务分配及绩效考核。培训和指导团队成员，提升团队的专业技能和故障处理能力。
Manage the mechanical maintenance team, including shift scheduling, task assignment, and performance evaluation. Train and mentor team members to enhance professional skills and troubleshooting capability.
5.制定并完善设备维护SOP，完成设备维护记录、故障报告及验证文件的填写和归档，确保团队严格执行。
Develop and refine equipment maintenance SOPs; complete and archive maintenance records, failure reports, and qualification/validation documents; ensure strict adherence by the team.
6.在项目关键阶段执行关键系统的FAT及SAT，见证安装质量。承担设备故障排查、根本原因分析及发展预防措施，解决相关系统范围内的问题。
Execute FAT and SAT for critical systems at key project stages and witness installation quality. Lead equipment troubleshooting, root cause analysis, and development of preventive measures to resolve issues within the system scope.
7.负责备品备件的库存管理，包括申购审批流转、订购及到货跟踪。与供应商协作维护设备运行。
Manage spare parts inventory, including requisition approvals, ordering, and delivery tracking. Collaborate with suppliers to sustain equipment performance.
8.严格执行公司EHS（环境、健康与安全）规程，确保设备维护和操作工作的安全性。识别维护过程中可能存在的安全隐患，并制定整改措施。定期组织设备相关的安全培训，提升团队安全意识。
Rigorously implement company EHS (Environment, Health and Safety) procedures to ensure the safety of maintenance and operational activities. Identify potential safety hazards during maintenance and define corrective actions. Conduct regular equipment-related safety training to enhance team safety awareness.
9.配合GMP要求，参与偏差调查、纠正预防措施（CAPA）的执行及变更管理工作。
Responsible for related deviation investigations, CAPA and change control execution.
10.完成上级安排的其它任务。
Other tasks as assigned by management.
5年以上制药行业设备维修维护经验，具备无菌药品生产设备（如隔离器、冻干机、灌装线、包装线等）维修维护管理经验者优先；具备ADC药品生产设备维修维护经验者优先；
At least 5 years of experience in pharmaceutical equipment maintenance and repair; experience in the maintenance and management of aseptic drug product equipment (e.g., isolators, lyophilizers, filling lines, packaging lines) is preferred; experience with ADC drug product manufacturing equipment is a plus.
熟悉GMP规范及医药行业设备维护标准和要求。
Well versed in GMP requirements and pharmaceutical equipment maintenance standards.
熟悉无菌药品生产设备的运行原理、维护保养及故障排查；
Familiar with the operating principles, preventive maintenance, and troubleshooting of aseptic drug product manufacturing equipment.
能够主导设备的安装、调试工作；
Able to lead equipment installation and commissioning.
了解PLC、自动化控制系统及相关设备软件的基本操作和维护；Knowledgeable in PLCs, automation control systems, and related equipment software; capable of basic operation and maintenance.
熟悉设备维修工具及检测仪器的使用；
Familiar with the use of maintenance tools and testing/diagnostic instruments.
有较强的沟通能力和团队合作精神。
Strong communication skills and teamwork.