Facility Engineer

协助部门负责人实施洁净生产车间相关动力、设备设施的日常运行管理、维保服务商管理、验证确认管理、计量管理，以及新建或改造设备设施的项目管理工作。<br>Assist facility manager to manage daily operation, maintenance, qualification, metrology and maintenance supplier of cleanroom related utility/ facility, and project management on new or renovation facility projects.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Main Responsibilities &amp; Tasks:</b></p><ul><li>制订洁净车间相关设备设施的维护保养计划&#xff0c;并按照计划监督日常维护、保养的执行&#xff0c;以确保洁净厂房在符合标准要求的情况下正常运行/To draft the cleanroom related facility maintenance plan, and to supervise the execution of daily maintenance, to ensure cleanroom is running in a good condition.</li><li>起草、完善体系要求的洁净厂房设施以及环境监控系统&#xff08;EMS&#xff09;相关SOP文件&#xff0c;并严格按照文件要求实施管理 /To draft, improve and maintain procedure documents of cleanroom facility and environment monitoring system, and manage the maintenance strictly according to documents.</li><li>负责设施相关不符合项的发起、调查&#xff0c;并相应制定纠正预防措施 /To draft facility related NC, and then investigate the root cause, and make CAPA plan accordingly.</li><li>负责设备设施的DQ/IQ/OQ/PQ等验证确认工作&#xff0c;以及定期回顾性验证工作&#xff0c;编写相关验证方案和验证报告, 包括洁净车间、压缩空气系统、纯化水系统、计算机化系统等。/Facility qualification work, such as DQ/IQ/OQ/PQ, and periodic facility re-qualification&#xff0c; drafting qualification protocol and report, including cleanrooms, compressed air sys, purifying water sys and CSV.</li><li>仪器仪表的校验管理/Calibration management.</li><li>内部库房的设备设施管理&#xff0c;进行相关的温湿度周期性确认工作/Facility management of internal warehouse, be responsible for warehouse humidity and temperature periodic requalification.</li><li>参与施工过程管理、完工验收工作 /Participate in construction management and acceptance of new projects.</li><li>完成上级交办的其它工作 / Other tasks assigned by facility manager.</li></ul><p></p><p><b>Qualifications &amp; Skills:</b></p><ul><li>本科及以上学历&#xff0c;暖通、机械、电气、自动化等理工科专业/Bachelor degree or above major in HVAC, mechanical, electrical, automation or engineering.</li><li>设备设施管理工作经验和工程类项目管理经验&#xff0c;8年以上医药类或医疗器械类洁净厂房设施&#xff0c;包括洁净空调、BMS/EMS、纯水、压缩空气等系统的施工、运行、验证确认管理经验 /Facility and engineering project management experience. More than 8 years pharmaceutical or medical devices industry cleanroom facility experience, including new project, operation, qualification management on HVAC, BMS/EMS, purified water, compressed air, ect.</li><li>GMP背景 /Solid GMP experience.</li><li>具备较强的沟通、协调、问题发现和解决&#xff0c;以及快速学习能力 /Good skill on communication, coordination, troubleshooting; Quick learner.</li><li>工作积极主动&#xff0c;责任心强&#xff0c;工作严谨细致&#xff0c;结果导向&#xff0c;抗压能力强/Proactive, strong sense of responsibility, strict and meticulous, result oriented, can work under pressure.</li><li>熟练使用Word&#xff0c;Excel等办公工具软件/Familiar with office tool such as Word, Excel, etc.</li><li>有一定英语读写水平为佳 /English capability is a plus</li></ul><p></p><p></p><p><b>About Sartorius </b></p><p></p><p>Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. </p><p></p><p>We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.</p><p></p><p>Join our global team and become part of the solution. We are looking forward to receiving your application. <br /><a href="https://www.sartorius.com/careers" target="_blank">www.sartorius.com/careers</a></p>