高级自动化工程师

Position : Sr Automation Engineer(BMS)
职位：高级自动化工程师（楼宇自控方向） BA / Dept. :
部门： 综合服务部 Central Services
Reporting to直接上司: Sr Technical Service Manager
GMP Related? GMP相关职位？ ☒Yes 是
☐No 否
Occupational Health Examination needed? 是否需要进行职业健康体检？ ☐Yes 是
☒No 否
Job Summary职位概述:
As a Senior Technical Expert (SME) in cleanroom controls, ensure the precision, stability, and compliance of our cGMP production environment through the masterful application of automation control technology. must possess a deep understanding of cleanroom HVAC processes, particularly the principles of pressure differential control and the operational logic of key equipment such as MAUs (Make-up Air Units), FCUs (Fan Coil Units), and FFUs (Fan Filter Units). lead the application of the Siemens Desigo CC Building Management System (BMS) and translate process requirements into stable and efficient DDC control programs, establishing yourself as a key figure in guaranteeing that the pharmaceutical production environment meets the most stringent regulatory requirements.
作为洁净室自控领域的资深技术专家 (SME)，是通过对自动化控制技术的精湛应用，来保障cGMP生产区域环境的精确、稳定与合规。需要深刻理解洁净室的HVAC工艺，特别是压差梯度控制的原理，以及MAU（组合式空调机组）、FCU（风机盘管）和FFU（风机过滤单元）等关键设备的运行逻辑。将主导西门子 Desigo CC 楼宇管理系统(BMS)的应用，并将工艺需求转化为稳定、高效的DDC控制程序，成为保障药品生产环境符合最严格法规要求的关键人物。
Main Tasks & Responsibilities主要工作职责 :
1. Cleanroom HVAC Process Control and DDC Programming:
洁净室HVAC工艺控制与DDC编程：
2. Deeply understand and implement stable control of cleanroom pressure differentials, ensuring that airflow patterns between areas of different cleanliness classifications comply with GMP requirements. 深刻理解并实现洁净室压差梯度的稳定控制，确保不同洁净级别区域间的气流组织符合GMP要求。
3. Develop, debug, and optimize the DDC control logic for key equipment such as MAUs (Make-up Air Units), FCUs (Fan Coil Units), and FFUs (Fan Filter Units) to ensure their efficient and reliable operation.
针对MAU（组合式空调机组）、FCU（风机盘管）、FFU（风机过滤单元）等关键设备，开发、调试并优化其DDC控制逻辑，确保其高效、可靠运行。
4. Optimize temperature and humidity control, dehumidification/reheat logic, and Variable Air Volume (VAV) system algorithms to achieve the dual goals of precise control and energy saving.
优化温湿度控制、除湿/再热逻辑以及变风量(VAV)系统算法，以达到精准控制与节能的双重目标。
5. As a DDC programming expert, proficiently use Siemens programming tools to perform low-level logic programming, debugging, and troubleshooting for controllers such as the PXC series.
作为DDC编程专家，精通使用西门子编程工具对PXC系列等控制器进行底层逻辑编程、调试和故障诊断。
6. BMS System and PLC Application
BMS系统与PLC应用
7. As the technical authority for the Siemens Desigo CC system, be responsible for the configuration and optimization of its graphical interface, alarm management, historical trending, and reporting systems. 作为西门子 Desigo CC 系统的技术权威，负责其图形界面、报警管理、历史趋势及报表系统的配置与优化。
8. Participate in the programming and maintenance of utility-related Siemens S7 series PLCs, with proficiency in using TIA Portal software.
参与公用工程相关西门子S7系列PLC的编程与维护，熟练使用TIA Portal (博图) 软件。
9. Compliance and Validation
合规与验证：
10. Lead the validation activities (FAT/SAT/IQ/OQ/PQ) for all BMS and HVAC automation-related projects, and be responsible for writing and reviewing key technical and validation documents.
主导所有BMS与HVAC自控相关项目的验证活动 (FAT/SAT/IQ/OQ/PQ)，并负责编写和审核关键技术与验证文件。
11. Ensure that all changes and operations of control logic strictly adhere to the requirements of cGMP, GAMP 5, and data integrity (ALCOA+).
确保所有控制逻辑的变更和操作严格遵守cGMP、GAMP 5以及数据完整性 (ALCOA+) 的要求。
12. System Optimization and Troubleshooting
系统优化与故障排除
13. Apply root cause analysis methodologies to solve complex cleanroom environmental control issues, such as pressure fluctuations and temperature/humidity excursions.
应用根本原因分析方法论，解决复杂的洁净室环境控制难题，如压差波动、温湿度超标等。
14. Continuously identify and implement improvement opportunities for the HVAC automation system to enhance system stability and operational efficiency.
持续寻找并实施对HVAC自-控系统的改进机会，提升系统稳定性和运行效率。
15. Other tasks as assigned by the head of the department.
部门领导分配的另外的任务。
Qualification & Experience任职资格:
Item
内容 Required
最低要求 Preferred
优先考虑
Education
教育背景
Bachelor's degree or above in Automation, HVAC, Mechatronics, or a related field.
自动化、暖通、机电一体化相关专业，本科及以上学历 Bachelor or above education background
本科以上学历
Qualification & Certification
资质证书 Electrical and Automation education or equivalent by experience
电气及自动化教育或同等学历 Bachelor or above degree in Electrical and Automation or equivalent by experience
电气及自动化专业本科以上学历或同等学历
Experience
工作经验: 1. > 5 years working experience
in a high regulated manufacturing site
5年以上工作经验或者更高级别的生产工厂
2. Familiar with problem solving methods
熟悉故障根本原因分析方法论。
3. PLC Programming: Proficient in Siemens TIA Portal software; capable of independently completing PLC projects for utility systems.
PLC编程：熟练掌握西门子 TIA Portal (博图) 软件，具备独立完成公用工程PLC项目的能力
4. Proficiency in BMS Platform: Possess a deep technical understanding of the Siemens Desigo CC platform, from front-end to back-end, with extensive experience in project implementation and maintenance.
熟悉BMS平台：具备对西门子 Desigo CC从前端到后端的深度技术理解和丰富的项目实施/维护经验。
5. "Over 5 years of automation-related work experience, with at least 3 years focused on the BMS systems and HVAC automation control field in pharmaceutical industry cleanrooms."
5年以上自动化相关工作经验，其中至少3年专注于制药行业洁净室的BMS系统和HVAC自控领域。 1. Experience in the design or operation and maintenance (O&M) of BMS/HVAC automation projects for large-scale sterile drug manufacturing facilities.
有大型无菌药品生产设施的BMS/HVAC自控项目的设计或运维经验
2. New equipment qualification and validation experience is a plus
有新设备验证或认证的经验更好
3. Experience in a highly regulated cGMP manufacturing environment.
具备生产工厂cGMP经验
4. Basic SHE ergonomics concept
基本的SHE概念
Professional Competencies
专业能力： 1. Familiar with electrical and automation principles, understanding of hardware and software design.
熟悉电气自动化原理，了解软硬件设计。
2. Knowledgeable in common of PLC and IPC- Hardware/Software such as STEP7, Portal, Zenon, WinCC.
具备PLC，IPC软件知识比如：
STEP7，博图，Zenon, WinCC.
3. Ability to convey concepts and report to different management levels and across functions within the Org.
能够向组织内不同的管理层和不同的职能部门传达概念和报告。
4. Project management skills. Good understanding of the commissioning and qualification process and activities
项目管理技能。良好的理解调试和验证过程与活动
5. 编程语言：掌握 C# 或Python等编程语言，用于数据分析或系统集成。 1. Experience in risk assessments such as PFMEA methodology
有风险评价的知识比如使用PFEMA工具
2. Knowledge of Kepware is preferred.
具备Kepware软件知识最好。
3. Knowledge of IBA is preferred.
具备IBA软件知识最好。
4.
Leadership Competencies领导能力：
Leadership competencies at proficient level, in line with corporate framework.
参照罗氏集团领导能力标准和要求，领导能力达到熟练水平
Remarks:
备注：
 SHE Responsibility please refer to RDSZ SHE handbook.
安全健康环保相关职责：请参照罗氏苏州安全健康环保手册，履行相应安全健康环保职责
 If positions are GMP related, please specify in job qualification according to requirements of China Medical Device GMP article 8 and IVD section 2.1.1.
技术、生产和质量管理部门岗位任职资格应符合中国医疗器械GMP 第八章和体外诊断试剂 小节 2.1.1