任职要求:
YOUR TASKS AND RESPONSIBILITIES
Responsible for equipment related projects, he or she can undertake from the beginning design to the final technical acceptance work, as well as the changes drafting and preparation of relevant URS/RA/DQ/IQOQ documents. 负责设备相关项目,能承担设备的设计选型到最后的技术验收工作, 以及相关变更起草和URS/RA/DQ/IQOQ等文件编写。
Responsible for drafting and updating SOP related to equipment engineering technology, as well as analyzing differences with Global related documents and taking corrective actions. 负责设备工程技术相关SOP 的起草和更新, 以及与Global相关文件的差异分析以及整改行动。
Responsible for developing project plans according to requirements, coordinate resources, and deliver equipment on time. 根据要求制定项目计 划,协调资源,按时交付设备。
Responsible for spare parts management, including standard process maintain & spare part BOM creation and purchasing. 负责设备备件管理及相 关SOP的起草和更新,备件及易耗品的采购。
Responsible for PM work instructions establishment and training technicians to perform maintenance work. Tracking and reviewthe actual execution to ensure the implementation as plan. 负责编写PM工作指导书并培 训技术员执行维护工作。跟踪回顾PM的执行情况,确保PM按计划执行。
CMMS (e.g. SAP FAM, Infor) & Object Identification System (AKZ). 负责 SAP FAM模块的管理和维护以及设备AKZ体系的建立和维护。
Build up robust maintenance system through ACA( Asset Criticality Analysis), FMEAs( Failure Mode Effective Analysis) and risk based methods. 通过ACA(资产关键性分析),FMEA(故障模式有效分析)和基于风险的 方法建立稳健的维护系统。
Able to analyze production data and lead technicians to improve production line equipment OEE to reduce failure rates.能够对生产数据进行 分析,带领技术员提高产线设备OEE降低故障率。
Responsible for the renovation of the hardware and software of the automation equipment, update the configuration according to production process requirements.负责公司自动化设备硬件、软件的改造与更新工作,根据 生产工艺要求,修改自动控制系统组态软件的控制方案。
Equipment system access control, audit trail review and system backup work.设备系统权限管理、审计追踪回顾、系统定期备份工作。
Complete relevant changes and CAPA of HSE and quality deviations.完 成相关的变更和HSE、质量方面偏差的CAPA整改。
The implementation of Equipment Re-qualification and equipment replacement strategic (ERS). 设备再确认的执行以及设备替换策略的计划和起 施。
WHO YOU ARE
Education: Bachelor's degree or above, major in Electrical Automation 教育: 本科以上学历,电气自动化专业背景
Experience: More than 5 years of work experience in pharmaceutical companies or multinational foreign companies. Must have work experience on equipment maintenance, installation, confirmation, qualification. 经验: 5年以上工作经历,有制药企业以及跨国外企工作经历优先。须有与设备维 修相关的工作经历,有进口设备的安装、调试、使用
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