工作内容CONTENT

1.压缩空气系统包括仪表压缩空气系统和洁净压缩空气系统和氮气系统。The compressed air system includes compressed air system and clean compressed air system and nitrogen system.

2.负责编写压缩空气系统相关用户需求标准（URS），提出设备采购申请。Responsible for drafting CA User Requirement Specification (URS) and proposing the application for equipment purchasing.

3.负责压缩空气系统设备验收，并撰写设备相关操作和维护SOP。Responsible for CA equipment acceptance and preparing SOPs related

equipment operation and maintenance.

4.负责监督压缩空气系统施工质量，安装调试期间协调。Responsible for supervising the construction quality of CA and coordinating

during installation and commissioning.

5.负责压缩空气系统设备预防性维护保养计划的制定和实施。Responsible for making and implementation CA equipment preventive maintenance plans.

6.负责压缩空气系统设备全生命周期管理，包括采购、调试、服役、退役。Responsible for the whole life cycle management of CA equipment, including procurement, commissioning, service and decommissioning.

7.负责压缩空气系统设备日常操作、维修。Responsible for CA equipment daily operations and maintenance and scrapping of equipment.

8.负责压缩空气系统设备技术档案的收集及管理。Responsible for collecting and managing CA equipment technical files.

9.负责建立压缩空气系统设备/仪表台账。Responsible for setting up CA equipment/instrument list.

10.负责压缩空气系统设备备品备件的选购。Responsible for selective purchasing CA equipment spare parts.

11.负责压缩空气系统设备突发问题的协调和解决。Responsible for coordinating and solving CA equipment emergent problems.

12.完成压缩空气系统变更、偏差调查和评估，并上报QA。Complete CA change and deviation investigation and evaluation, and report

to QA.

13.对设备和厂房的变更做出评估。Evaluate the changes of equipment and workshop.

14.配合完成第三方和客户审计和参观等事情。Cooperate with third party and customer audits and visits.

15.完成其他相关工作。Execute other related tasks.

教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION

1.药学、机电、机械或其他相关专业本科及以上学历。College degree or above in pharmaceutical, electromechanical, mechanical or other related majors.

2.两年以上制药或相关行业设施安装、维修及保养工作经验。More than 2 years’ experience in equipment installation, repair and maintenance in pharmaceutical or related industries.

3.熟悉药品质量规范和GMP标准。Familiar with drug quality specifications and GMP standards.

4.具备压缩空气系统验证及相关工作经验。Have the experience in CA validation and related work.

5.具备专业技术能力，具备专业的机械设备安装、维修以及保养知识，具备熟练的设备维修及保养操作技能。Have professional technical ability, have professional knowledge of mechanical equipment installation, repair and maintenance, and have skillful operational skills of equipment repair and maintenance.

6.具备较强的问题分析、判断及解决能力。Have strong ability of problem analysis, judgment and resolution.

7.具备良好的沟通交流能力。Have good communication ability.

8.熟练使用Office、CAD等办公软件。Skilled in Office, CAD, and other office software.

9.具备一定的英语读写能力。Have Good English reading and writing skills.