工作描述简述Brief Job Description
概述工作的目的或角色及其在组织内的价值Summarizes the job’s purpose or role and why it exists in the organization
岗位工作地点在青岛。 项目建设期间参与项目前期的设计，建造，调试和确认等工作，作为用户代表更好的支持项目组实现青岛pMDI工厂的建设。通过精益标准化和专业技能持续标准化与改善如SOP/工作指导以确保项目期间的知识，技能和经验能够传承以支持未来的商业化生产，并在项目早期就注重工艺/设备/操作等的持续改善工作。能够运用如精益尤其如TPM等工具和理念。加强和内外部利益相关方的沟通。
进入商业化生产期间，在遵守安全、GMP的前提下,正确、有效的执行维护计划，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，以支持pMDI工厂生产及供应的核心业务流程,达成领先的SQSCP的绩效。同时不断提高技术能力，就设备方面的问题与内部和外部客户建立高效的沟通。
This role is based in Qingdao. During project phase involved in project Design、Construction、Commissioning and Qualification as end user to support Global engineering team/Project team to deliver Qingdao pMDI project. And standardize knowledge and experience during project and startup phase to prepare for Qingdao site PQ and PV and ensure following BAU smoothly in terms of daily operation including SOP/WI ready and continuously improve process/equipment/operation from project to BAU transition. Practice lean/TPM from end-to-end mindset and have good communication internally and externally.
When moving into BAU, To comply SHE and GMP，through appropriate prevent maintenance plan-making ,conducting maintenance activities effectively ,quick response to trouble-shooting ,make sure all the equipment in safe, high-yield manner to support the core business process of pMDI site to achieve top decile performance of SQSCP. Improve the professional capability constantly, communicate with external and internal customer and supplier for machine issue.
具体职责/任务
Specific Responsibilities/Tasks
01 参与到项目的不同阶段，作为最终用户提供有价值和专业的建议到项目建设中
Fully involved in different project phase and have valuable input as end user
01 学习并运用其他工厂和行业的***实践到新工厂
Learn and apply best practice from other sites and other experiences to Qingdao project
01 端到端的思维持续标准化和持续改善的理念和能力，通过项目期间的参与，实践为未来的商业化生产的垂直启动和成功做好充足的准备
End to end mindset to be involved in project and ensure standardization and continuous improvement to BAU vertical startup through expertise, lean and experience gained from project phase
01 良好的问题解决能力和持续改进的能力，确保项目C&Q,PQ/PV的成功
Strong PPS and CI capability to ensure C&Q, PQ/PV successfully

生产设备维护
Production equipment maintenance
01 负责对配料&制剂&罐装设备维护及软件管理，定期进行预防性维护, 准确及时填写设备维护，维修记录
Responsible for dispending &formulation & filling equipment maintain and software management, carry out routine preventive maintenance plan together with engineering group, fill and keep preventive maintenance and repairing records correspondingly and timely
01 及时解决生产中出现的设备故障
Identify equipment fault and perform prompt and efficient repairing
01 根据现场经验提交维护体系更新建议
Submit update suggestion to maintenance system based on shop floor experience
01 如需要，起草相关工作指导或标准操作规程
Draft technique WI/SOP as required
01 及时定购设备备品备件，以满足生产的需求。

设备改造
Equipment modification and improvement
Engineering spare parts ordering and stock management to support production needs
01 对配料&制剂&灌装设备及软件的缺陷进行改造以使其更好的发挥性能
Modify any defectives of dispensing & formulation & filling equipment and software to get better performance with creative and effective solution
01 起草设备升级改造的验证文件
Draft verification document for equipment update/modification
01 生产流程优化建议
Suggestion for optimizing operation procedure

设备操作Equipment operation and validation support
01 需要时，在批生产过程中负责相关设备操作,（如隔离器、制剂系统、灌装机）
Operate certain equipment in proper way when production batch happens when required.（such as isolator、formulation system、filling machine）
01 在维护或维修过程中，能以超级用户运用设备服务功能。
Be able to operate related machines within service function as super user while maintaining and repairing
01 给验证或再验证提供支持
Support Validation & Revalidation activity.


工作要求Job Requirement
教育、资质、技能、经验和能力Education, Qualifications, Skills, Experience and Capabilities
工程领域的本科或以上学历
Bachelor or above degree, major degree in engineering field
机械，电气电子，工业自动化知识
Mechanical & Electrical & Electronic knowledge, Industrial automation
具备过程控制系统软件编程能力和丰富的调试能力，问题的排查以及较高的沟通协调能力：
熟悉配料、制剂、罐装工艺设备和技术方案
Be familiar with Dispensing、Formulation 、Filling process equipment and technical solutions
熟悉主流DCS/PLC编程软件，以及批次生产的执行经验
Be familiar with main DCS/PLC soft programming and the implementation experience of batch product
熟悉Profibus-net/DP，Modbus和FF通讯协议
Be familiar with Profibus-net/DP，Modbus and FF communication protocols
熟悉自动控制系统中各种传感器的基本工作原理
Be familiar with the basic working principle of various sensors in automatic control system
能够熟练的进行英语读说
Reading and speak English very well
Good MS office skill and digital mindset
熟练应用微软常用办公软件以及数字化的相关理念