职位描述Job Description

岗位工作地点在青岛，项目期间以及后续生产会出差的需求，如上海，无锡，泰州等。

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：精益和TPM等工具和理念。加强和内外部利益相关方的沟通。

作为工程部技术员，通过提高运行效率及可靠性提供高质量的公用介质和设施系统，以支持pMDI工厂生产及供应的核心业务流程，在项目和商业化生产期间达成领先的SQSCP的绩效。同时促进自身技术能力不断提高，就设备、设施方面的问题参与讨论与沟通。

This role is recruited for pMDI Qingdao site, permanent location will be in Qingdao，will need travel.

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.

As utility Technician to supply high quality media and system through improvement of cost efficiency and reliability to support the core business process of pMDI site during both project and BAU period to achieve top decile performance of SQSCP. At the same time, promoting the continuous improvement of our own technical capabilities and participate in discussions and communications on issues related to equipment and facilities.

职责（包括关键结果领域、具体责任、任务等） Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)

· 作为最终用户参与和支持青岛工厂的项目建设

Ø 全面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

Ø 学习并运用其他工厂和行业的最佳实践到青岛工厂

Ø 将精益和TPM和先进的维修理念运用到项目执行和后续的商业化生产

Ø 良好的问题解决能力和持续改进的能力。

· 公用工程系统运行管理

Ø 具备公用工程及设备维护经验（例如：楼宇控制系统，暖通空调系统，纯水系统，纯蒸汽系统，注射用水系统，供配电系统，给排水系统等）

Ø 熟练判断公用工程设备常见故障，并具备一定的故障处理及应急处理能力

Ø 通过对设计文件的熟悉，参与项目安装、调试、验证，以及系统操作维护培训，熟悉公用工程系统

Ø 为工程系统提供意见

Ø 执行工程部维修策略，开展预防性维修活动。对公用工程系统的问题进行快速解决、总结，研究并解决影响系统稳定的突出问题，合理控制维修费用。

· 维护保养

Ø 开展预防性维护维修工作；

Ø 协助协调好预防性维护、工程安装、紧急维护的工作安排；

Ø 协助确保维护维修相关的工作内容规范记录及存档；

Ø 依照操作规程及相关规定技术要求实施常规检查及测试工作，并实施设备工况调整工作；

Ø 参与相关的验证测试工作；

Ø 在日常的工作中遵守安全作业相关规定及行业施工规范；

Ø 及时实施紧急维修；

Ø 准确实施物料的入库出库和清点；

· 安全环境健康责任

Ø 提供一个安全、健康的工作环境，识别和评估场所内存在的安全、健康与环境的风险。

Ø 保持一个可靠的程序以确保风险评估系统的建立、职责的分配和控制措施有效性的回顾。

Ø 了解其需要承担的安全、健康及环境的责任及义务，并根据其工作性质进行了相关的培训，以确保其工作的安全性，同时，在工作中减少环境污染，确保一切行为均满足安全、健康与环境的政策并与国家的法律、法规与当地的其它规定相符合。

Ø 确保来访人员了解并遵循与其安全相关的本公司的规章制度。

Ø 确保所有的事故、事件以及不符合项均得到了汇报、调查并采取了整改措施。

· GMP 要求

Ø 理解业务活动中涉及GMP的相关内容及可能对产品质量产生的影响

Ø 参加GMP相关培训，确保业务活动持续符合GMP要求

Ø 严格执行本岗位的GMP相关规程

Ø 向直线经理或QA沟通工作中遇到的GMP相关问题

· 利益相关方

Ø 与工厂内外其他团队建立并保持良好的业务关系

· 其它职责

Ø 根据工作需要完成文件工作

Ø 提供跨部门支持

· Support project team to deliver Qingdao pMDI project as end user

Ø Fully evolve in different stages of the project and provide valuable and professional suggestions to the project construction as an end user.

Ø Learn and apply the best practices of other factories and industries to Qingdao Factory

Ø Apply lean and TPM and advanced maintenance concepts to project execution and subsequent commercial production.

Ø Good problem-solving and continuous improvement capabilities.

· Utility system operation management

Ø Experience inutility system and equipment maintenance (e.g.BMS, HVAC, PW PA, water for injection systems, water supply and drainage systems, etc.)

Ø Proficient in judging common faults of utility equipment and possessing certain fault handling and emergency handling capabilities

Ø Familiar with utility systems through familiarity with design documents, participation in project installation, commissioning, verification, and system operation and maintenance training

Ø Provide advice for utility systems

Ø Implement the maintenance strategy of the engineering department and carry out preventive maintenance activities. Quickly solve and summarize problems in utility systems, study and solve outstanding problems that affect system stability, and reasonably control maintenance costs.

· Maintenance

Ø Perform preventive maintenance or repairing activities

Ø To help coordinate preventative maintenance, engineering, installation, emergency maintenance work arrangements

Ø help ensure that maintenance and repair work related to the content of authority records and archives

Ø Implement routine inspection and testing in accordance with the procedures and technical requirements of the relevant regulations and the implementation of equipment condition adjustment

Ø Participate in relevant validation testing

Ø comply with safety regulations and industry jobs construction norms in everyday work

Ø timely implementation of emergency repairs

Ø accurate implementation of material storage and inventory

· Safety, environment and health responsibilities

Ø Provide a safe and healthy working environment, identify and evaluate the safety, health and environmental risks in the site.

Ø Maintain a reliable procedure to ensure the establishment of a risk assessment system, the allocation of responsibilities and the review of the effectiveness of control measures.

Ø Understand the responsibilities and obligations of safety, health and environment that they need to bear, and conduct relevant training according to the nature of their work to ensure the safety of their work. At the same time, reduce environmental pollution at work, ensure that all behaviors meet the safety, health and environmental policies and comply with national laws, regulations and other local regulations.

Ø Ensure that visitors understand and follow the company's rules and regulations related to their safety.

Ø Ensure that all accidents, incidents and non-conformities are reported, investigated and corrective measures are taken.

Ø Supervise and manage employees in functional departments to ensure that they assume the responsibility for managing safety, health and environmental risks within their respective responsibilities, and include their safety, health and environmental performance in their respective job evaluation and promotion mechanisms.

· GMP requirements

Ø Understand the relevant content of GMP in business activities and the possible impact on product quality.

Ø Participate in GMP-related training to ensure that business activities continue to meet GMP requirements.

Ø Strictly implement GMP-related procedures for this position

Ø Communicate GMP-related issues encountered in work to line managers or QA

· Stakeholders

Ø Establish and maintain good business relationships with other teams inside and outside the factory.

· Other tasks

Ø Paperwork or report upon request.

Ø Provide cross-departmental support.

必备条件 Essential

· 工程领域的专科或以上学历

· 1-3年工程领域经验

· Colledge or above degree, major degree in engineering field

· 1-3 years’ experience in the engineering field

· Digital solution experience

· 掌握精通如下系统或技能

Ø 公用工程运行及维修

Ø 良好药品生产规范

Ø 系统调试&验证

· Master the following systems or skills:

Ø Utility operation and maintenance (Power receiving and distribution, PW&WWTP system, HVAC & Plumbing, CAS system、etc.)

Ø GMP

Ø System Commissioning & Validation

· 熟练应用微软常用办公软件以及数字化的相关理念

· 具备CAD 软件使用和西门子触摸屏, PLC 和工业控制计算机软件常规操作及维护的技能

· Good MS office skill and digital mindset

· Know about AutoCAD and Siemens touch panel, PLC and IPC software maintenance skills are preferred

· 个人特性

Ø 与团队成员真诚交流

Ø 在高强度工作压力下具有很强的责任感

Ø 团队工作精神，乐于培训和发展团队成员的技能

· Personal character

Ø Be honest to communicate with each other in team.

Ø Be responsible under high work pressure.

Ø High teamwork spirit and be willing to train and develop team member skills

优先条件 Desirable

· 1-3年跨国制药企业公用工程及设施运行/维修工作经验

· 具有项目或者新工厂启动相关的工作经验

· 1-3 years utility &facility operation/ maintenance experience in multinational Pharmaceutical company

· Have project or new site startup related experience