Main Responsibilities & Tasks:

•制订洁净车间相关设备设施的维护保养计划，并按照计划监督日常维护、保养的执行，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.

•起草、完善体系要求的洁净厂房设施以及环境监控系统（EMS）相关SOP文件，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.

•负责设施相关不符合项的发起、调查，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.

•负责设备设施的DQ/IQ/OQ/PQ等验证确认工作，以及定期回顾性验证工作，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， drafting qualification protocol and report, including cleanrooms, compressed air sys, purifying water sys and CSV.

•仪器仪表的校验管理/Calibration management.

•内部库房的设备设施管理，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.

•参与施工过程管理、完工验收工作 /Participate in construction management and acceptance of new projects.

•完成上级交办的其它工作 / Other tasks assigned by facility manager.

Qualifications & Skills:

•本科及以上学历，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.

•设备设施管理工作经验和工程类项目管理经验，8年以上医药类或医疗器械类洁净厂房设施，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.

•GMP背景 /Solid GMP experience.

•具备较强的沟通、协调、问题发现和解决，以及快速学习能力 /Good skill on communication, coordination, troubleshooting; Quick learner.

•工作积极主动，责任心强，工作严谨细致，结果导向，抗压能力强/Proactive, strong sense of responsibility, strict and meticulous, result oriented, can work under pressure.

•熟练使用Word，Excel等办公工具软件/Familiar with office tool such as Word, Excel, etc.

•有一定英语读写水平为佳 /English capability is a plus