Qualifications (minimum requirements) 任职资格
Education Background: 教育背景
• Bachelor Degree, major in HVAC engineering or other relevant fields.
暖通空调工程相关专业大学本科学历。
• Fluent in written and reading English. 流利的英语听说技能。
Professional Experience专业经验:
• Minim 3-5 years of manufacturing working experience in pharmaceutical industry or in life science industry. 至少3-5年制药相关行业生产制造工作经验。
• Minim 3 years engineering experience in maintenance of HVAC system, design, smoothly running, process improvement, and root cause analysis. 至少3年暖通空调系统设计、维护、稳定运行、工艺改进以及故障根本原因分析等技术的工程类经验。
• Have the knowledge of HVAC for clean area, process improvement methodologies, root cause analysis, reliability centered maintenance, pharmaceutical utilities. 具备无菌公用工程暖通空调系统相关的工艺改进方法论知识、故障根本原因分析能力、系统可靠性维护经验和制药公用设施知识。
• Have the knowledge of Part 11 & GMP standards, experience within cGMP, ISO9000, ISO14000. 具有cGMP，GMP，ISO9000，ISO14000标准的知识和经验。
• Proven expertise in planning/organization/execution of maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams. 具备专业的计划、组织、实施维修活动的经验，跟踪活动结果，能够根据跨部门解决复杂问题的需要修改工作计划。
Job content工作内容描述
Key areas of responsibility 主要工作职责:
HVAC engineer is responsible for compliance of daily system running and maintenance activi-ties that to ensure quality and efficiency of production. Work according to cGMP, GMP, GDP and SOP. Ensure NC, CR, QAP, validation, etc. are accomplished within schedule.
暖通空调工程师的职责是保证日常设备系统运行和维护活动合规，保证生产高质、高效。遵循cGMP 、GMP、GDP和SOP执行工作，确保NC、CR、QAP、验证等工作按计划完成。
Main Job Tasks 主要工作任务:
• Perform process specialist support on site.
执行现场工艺专家支持
-Be an important part of establishing and operating HVAC/FMS/BMS system in Site Tianjin.担当天津工厂建立和运行暖通空调/公用设施监控/楼宇监控系统的重要角色。
-Perform event and process analysis via root cause analysis tools and techniques.
利用根本原因分析的工具对事件和流程进行分析。
-Participate all relevant validation activities within HVAC area.
参与HVAC范畴内所有验证活动。
-Participate in HVAC/cold room project installation and validation.
参与HVAC/冷库项目的设备安装和验证。
-Operate SAP system related to HVAC data maintenance and spare parts management.
操作SAP系统，维护HVAC相关数据以及进行备件管理。
-Ensure FMS batch reports are approved timely.
确保FMS报告及时审批。
-Establish and maintain SOPs and other required documents.
建立和维护标准操作流程以及其他要求的文件。
-Handle CR and NC. 处理CR和NC
• Ensure daily support to production units and support units within the process area including: 确保对生产部门的日常支持及对本工艺范畴内部的支持：
-Ensure that efficient process KPIs are defined and followed up upon.
设立高校的KPI指标并跟踪执行。
-Drove problem solving/event response to local problems and comprehensive NCs.
推动问题解决和复杂不符合事件的解决。
-Identify improvement opportunities and implement locally with documented benefit and drive local improvement projects. 寻找改进机会、执行并记录下来，领导改进项目。
-Responsible for developing and maintaining local procedures and standards within the pro-cess area. 负责在工艺范畴内规程和标准的发展和维护。
-Systematic knowledge sharing within the site and training of site employees in collaboration with site training coordinator.
在天津工厂内与培训协调员合作系统化地进行知识分享和员工合作。
•Participate in validation, technology transfer and process improvements during project exe-cution and operatio including: 参与验证活动、技术转移和工艺改进：
-Ensure validation, qualification, requalification and verification of processes, machines and equipment. 确保实施对工艺流程、机器及设备的验证、资质、再验证及核查确认。
-Responsible for event response and NC handling during validation.负责处理验证期间的事件响应和NC处理。
-Review and approve validation documentation and share best practice for validation with relevant stakeholders.审核并批准验证文件并与利益相关者分享实践方法。
-Develop and review CR cases for relevant changes including update of One DFP standards. 为包括one DFP标准在内的相关变更撰写并审核CR。
-Do event and process analysis via Root Case Analysis (RCA) tools and techniques.利用根本原因分析工具和技术完成事件和工艺分析。
-Assist in the development and implementation of equipment reliability improvement projects. 协助发展和实施设备可靠性改进项目。
-Assist in maintaining standards for procedures and maintenance plans.
协助维护标准以用于程序和维修计划。
-Develop quality mindset in the area. Ensure compliance with legal or requlatory requirements and the NN quality system including policies and safety rules.
在部门内发展质量意识；确保诺和诺德质量体系内及法律法规范围内的合规性，包括政策合规和安全规定的合规。
-Contribute to uniform polices/procedures/standards/processed/systems in production area based on NN and industry best practices within processes, equipment, systems to meet cGMP requirement. 根据诺和诺德和行业内工艺、设备及系统标准，推进生产区域内着装政策/步骤/标准/系统的完善以达到cGMP要求。