(高级)公用设施工程师(暖通,CU,电气)

/ Job Description

负责厂房公用设施系统的运行维护与技术支持，包括暖通系统、洁净公用设施及电气相关系统，确保系统安全、稳定、合规运行，并支持工程项目及持续优化工作。

Responsible for operation, maintenance, and technical support of facility utility systems, including HVAC, clean utilities, and relevant electrical systems, ensuring safe, stable, and compliant operation, while supporting engineering projects and continuous improvement.

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岗位职责 / Job Responsibilities

1. 公用设施运行与维护

负责厂房公用设施系统的日常运行与维护，包括暖通系统、电力系统及洁净公用设施。

Responsible for daily operation and maintenance of facility utility systems, including HVAC, power systems, and clean utilities.

确保系统稳定运行并满足生产需求。

Ensure stable system performance to support production operations.

执行巡检、维护及保养工作。

Perform inspection, maintenance, and preventive maintenance activities.

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2. 洁净公用设施管理

负责洁净公用设施的运行与维护，如纯化水、注射用水、洁净蒸汽及压缩空气系统。

Manage operation and maintenance of clean utilities, such as purified water, WFI, clean steam, and compressed air systems.

参与洁净公用设施调试、验证及再验证工作。

Participate in commissioning,

, and requalification of clean utilities.

确保系统持续符合GMP要求。

Ensure systems remain compliant with GMP requirements.

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3. 厂房及洁净室支持

支持厂房及洁净室相关系统运行与维护，包括空调、配电及相关支持系统。

Support operation and maintenance of facility and cleanroom systems, including HVAC, power distribution, and supporting systems.

配合生产及QA，确保洁净室环境稳定。

Work with Production and QA to ensure cleanroom environment stability.

参与洁净室异常处理及问题解决。

Participate in troubleshooting and resolving cleanroom-related issues.

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4. 故障处理与持续改进

负责公用设施系统故障诊断及处理。

Troubleshoot and resolve utility system failures.

开展根因分析并推动CAPA实施。

Conduct root cause analysis and drive CAPA implementation.

持续优化设备运行及维护策略。

Continuously optimize system performance and maintenance strategies.

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5. 工程项目及改造支持

参与公用设施相关工程建设及改造项目。

Participate in engineering construction and retrofit projects for utility systems.

支持设备安装、调试及项目交付。

Support installation, commissioning, and project delivery.

协助完成FAT、SAT及IQ/OQ等活动。

Assist in FAT, SAT, and qualification activities.

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6. 合规与质量管理

起草及修订相关GMP文件，包括变更、偏差及CAPA。

Draft and revise GMP documents, including change controls, deviations, and CAPA.

支持内部及外部审计，确保系统合规。

Support internal and external audits to ensure compliance.

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7. 数据与设备管理

负责设备运行数据收集与分析。

Collect and analyze equipment performance data.

参与设备生命周期管理及优化。

Participate in equipment lifecycle management and optimization.

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任职要求 / Job Requirements

教育背景 / Education

本科及以上学历，暖通、电气、环境工程或机电相关专业优先。

Bachelor’s degree or above in HVAC, Electrical, Environmental Engineering, or related disciplines.

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工作经验 / Experience

5年以上制药或相关行业公用设施工作经验。

Minimum 5 years of experience in utilities engineering in pharmaceutical or related industries.

具备暖通、洁净公用设施或电气系统相关经验。

Experience in HVAC, clean utilities, or electrical systems.

具备工程项目或设备改造经验优先。

Experience in engineering projects or system retrofit is preferred.

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专业能力 / Technical Competence

熟悉公用设施系统运行原理及维护要求。

Familiar with operation and maintenance of utility systems.

熟悉洁净公用设施及GMP要求。

Familiar with clean utilities and GMP requirements.

具备故障诊断及问题解决能力。

Strong troubleshooting and problem-solving capability.

具备基础验证及文档管理能力。

Basic knowledge of qualification and documentation management.

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综合能力 / Soft Skills

具备良好的沟通能力及团队协作能力。

Good communication and teamwork skills.

具备较强执行力及学习能力。

Strong execution and learning capability.

具备持续改进意识。

Continuous improvement mindset.