设备维护工程师

Job Responsibilities/工作职责
Fulltime maintenance and engineering for the utilities and facilities of CBL facilities in Wuhan, China. This function is responsible for the CBL-1 commercial facilities, administrative, and Laboratories:
全职运营和维护，负责CBL工厂在中国武汉的工艺设备、公用设施和设备。该职能负责CBL-1的商业生产设施、非商业和开发实验室和设施：

1. Site Safety
工厂安全
1) Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.
通过个人领导和建立安全管理标准程序，发展和维护安全工作实践的文化。

2) Following the system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems. Zero lost -time injuries.
遵循工作安全评估制度，发放工作许可证，包括带电和危险系统的上锁挂牌。零失时工伤。

2. Ensure that the company's public facilities and process production equipment that directly affect the company are maintained in a reliable, qualified and effective state.
确保公司的直接影响公用设施设备和工艺生产设备保持在可靠、合格和有效的状态。

3. Responsible for the management, maintenance and repair equipment. Cooperate with other function module engineers to carry out repair and calibration and maintenance.
负责管理和维护、维修设备。配合部门其它功能模块的工程师执行维修、校准、保养事宜
4. Manage and supervise the maintenance and operation of contractors and suppliers.
管理和监督承包商和供应商的维护和操作。

5. Active participation in the development and implementation of the Company Quality Management System, and responsible for the GMP documentation handling of DEV, CR, CAPA for utilities and equipment.
积极参与公司质量管理体系的开发和实施，负责设施设备的偏差、变更、CAPA的GMP文件处理。

6. Site Facility operation and maintenance function including:
现场设施运行和维护功能，包括：

1) Buildings Maintenance Service, Clean and maintain plant utilities and equipment.
楼宇维修服务，清洁和维护工厂公用设施设备。

2) HVAC (Classified Cleanrooms and general areas), Water for Injection system, Purified water system.
HVAC（分类洁净室和一般区域）、注射用水系统、纯化水系统。

3) Breakdown repair and trouble-shooting of utility
公用工程的故障检修，电力系统（包括应急发电机）的应急处理。

7. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
为维护计划的管理和执行准备标准操作程序和相关记录。

8. Complying with cGMP and local GB requirements.
符合cGMP和本地GB要求。


Job Requirements/岗位要求
1. College degree or Bachelor degree (mechanical or electrical preferred) with at least 3 years working experience in pharmaceutical industry, or at least 5 years working experience in medical device, healthcare or food industry.
大专或本科(机械或电气优先)，至少3年制药行业工作经验，或至少5年医疗器械、医疗保健或食品行业工作经验。

2. Be familiar with the repair and maintenance knowledge of process equipment produced in the factory, such as fill finish equipment, biological stock production equipment, QC laboratory equipment, Liquid nitrogen refrigerator etc.
熟悉工厂生产的工艺设备的维修、维护知识，例如，制剂灌装设备、生物原液生产设备、QC实验室设备、液氮冰箱设备等。

3. Basic knowledge and understanding of facility and utilities for biopharmaceutical processes.
对生物制药流程的设备和设施有基本的知识和理解。

4. Strong verbal and written communication skills in English and Mandarin (Read, Write, Verbal).
较强的英语和普通话的口头和书面沟通能力（读、写、说）。

5. Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities.
具备良好的工程实践(GEP)知识，包括制药设施的文件编制和设备选型。

6. Sound Understanding of Good Manufacturing Practice (GMP)
充分理解良好的生产规范（GMP）

7. Hands-on experience in maintenance of pharmaceutical utility system s (e.g. PW, WFI, Pure Steam , Compressed Air, and HVAC) and filling production line (such as isolator and filling machine), raw liquid production equipment (such as bioreactor), QC laboratory equipment (such as liquid nitrogen refrigerator and detection instrument) , and general building systems (e.g. access control, boiler, waste neutralization , chillers, cooling towers, electrical power , emergency generators, compressed gas) .
了解制药公用设施系统(如PW, WFI，纯蒸汽，压缩空气和HVAC)和灌装生产线（如隔离器、灌装机）和原液生产设备（如生物反应器）、QC实验室设备（如液氮冰箱、检测仪器）等功能块的维护知识，以及一般建筑系统(如门禁控制，锅炉，废物中和，冷水机，冷却塔，电力，应急发电机，压缩气体)维护的实际经验。