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Position : Sr Automation Engineer(BMS)
職位：高級自動化工程師（樓宇自控方向） BA / Dept. :
部門： 綜合服務部 Central Services
Reporting to直接上司: Sr Technical Service Manager
GMP Related? GMP相關(guān)職位？ ?Yes 是
?No 否
Occupational Health Examination needed? 是否需要進行職業(yè)健康體檢？ ?Yes 是
?No 否
Job Summary職位概述:
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.
作為潔凈室自控領(lǐng)域的資深技術(shù)專家 (SME)，是通過對自動化控制技術(shù)的精湛應用，來保障cGMP生產(chǎn)區(qū)域環(huán)境的精確、穩(wěn)定與合規(guī)。需要深刻理解潔凈室的HVAC工藝，特別是壓差梯度控制的原理，以及MAU（組合式空調(diào)機組）、FCU（風機盤管）和FFU（風機過濾單元）等關(guān)鍵設(shè)備的運行邏輯。將主導西門子 Desigo CC 樓宇管理系統(tǒng)(BMS)的應用，并將工藝需求轉(zhuǎn)化為穩(wěn)定、高效的DDC控制程序，成為保障藥品生產(chǎn)環(huán)境符合最嚴格法規(guī)要求的關(guān)鍵人物。
Main Tasks & Responsibilities主要工作職責 :
1. Cleanroom HVAC Process Control and DDC Programming:
潔凈室HVAC工藝控制與DDC編程：
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. 深刻理解并實現(xiàn)潔凈室壓差梯度的穩(wěn)定控制，確保不同潔凈級別區(qū)域間的氣流組織符合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.
針對MAU（組合式空調(diào)機組）、FCU（風機盤管）、FFU（風機過濾單元）等關(guān)鍵設(shè)備，開發(fā)、調(diào)試并優(yōu)化其DDC控制邏輯，確保其高效、可靠運行。
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.
優(yōu)化溫濕度控制、除濕/再熱邏輯以及變風量(VAV)系統(tǒng)算法，以達到精準控制與節(jié)能的雙重目標。
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.
作為DDC編程專家，精通使用西門子編程工具對PXC系列等控制器進行底層邏輯編程、調(diào)試和故障診斷。
6. BMS System and PLC Application
BMS系統(tǒng)與PLC應用
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. 作為西門子 Desigo CC 系統(tǒng)的技術(shù)權(quán)威，負責其圖形界面、報警管理、歷史趨勢及報表系統(tǒng)的配置與優(yōu)化。
8. Participate in the programming and maintenance of utility-related Siemens S7 series PLCs, with proficiency in using TIA Portal software.
參與公用工程相關(guān)西門子S7系列PLC的編程與維護，熟練使用TIA Portal (博圖) 軟件。
9. Compliance and Validation
合規(guī)與驗證：
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.
主導所有BMS與HVAC自控相關(guān)項目的驗證活動 (FAT/SAT/IQ/OQ/PQ)，并負責編寫和審核關(guān)鍵技術(shù)與驗證文件。
11. Ensure that all changes and operations of control logic strictly adhere to the requirements of cGMP, GAMP 5, and data integrity (ALCOA+).
確保所有控制邏輯的變更和操作嚴格遵守cGMP、GAMP 5以及數(shù)據(jù)完整性 (ALCOA+) 的要求。
12. System Optimization and Troubleshooting
系統(tǒng)優(yōu)化與故障排除
13. Apply root cause analysis methodologies to solve complex cleanroom environmental control issues, such as pressure fluctuations and temperature/humidity excursions.
應用根本原因分析方法論，解決復雜的潔凈室環(huán)境控制難題，如壓差波動、溫濕度超標等。
14. Continuously identify and implement improvement opportunities for the HVAC automation system to enhance system stability and operational efficiency.
持續(xù)尋找并實施對HVAC自-控系統(tǒng)的改進機會，提升系統(tǒng)穩(wěn)定性和運行效率。
15. Other tasks as assigned by the head of the department.
部門領(lǐng)導分配的另外的任務。
Qualification & Experience任職資格:
Item
內(nèi)容 Required
最低要求 Preferred
優(yōu)先考慮
Education
教育背景
Bachelor's degree or above in Automation, HVAC, Mechatronics, or a related field.
自動化、暖通、機電一體化相關(guān)專業(yè)，本科及以上學歷 Bachelor or above education background
本科以上學歷
Qualification & Certification
資質(zhì)證書 Electrical and Automation education or equivalent by experience
電氣及自動化教育或同等學歷 Bachelor or above degree in Electrical and Automation or equivalent by experience
電氣及自動化專業(yè)本科以上學歷或同等學歷
Experience
工作經(jīng)驗: 1. > 5 years working experience
in a high regulated manufacturing site
5年以上工作經(jīng)驗或者更高級別的生產(chǎn)工廠
2. Familiar with problem solving methods
熟悉故障根本原因分析方法論。
3. PLC Programming: Proficient in Siemens TIA Portal software; capable of independently completing PLC projects for utility systems.
PLC編程：熟練掌握西門子 TIA Portal (博圖) 軟件，具備獨立完成公用工程PLC項目的能力
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平臺：具備對西門子 Desigo CC從前端到后端的深度技術(shù)理解和豐富的項目實施/維護經(jīng)驗。
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年以上自動化相關(guān)工作經(jīng)驗，其中至少3年專注于制藥行業(yè)潔凈室的BMS系統(tǒng)和HVAC自控領(lǐng)域。 1. Experience in the design or operation and maintenance (O&M) of BMS/HVAC automation projects for large-scale sterile drug manufacturing facilities.
有大型無菌藥品生產(chǎn)設(shè)施的BMS/HVAC自控項目的設(shè)計或運維經(jīng)驗
2. New equipment qualification and validation experience is a plus
有新設(shè)備驗證或認證的經(jīng)驗更好
3. Experience in a highly regulated cGMP manufacturing environment.
具備生產(chǎn)工廠cGMP經(jīng)驗
4. Basic SHE ergonomics concept
基本的SHE概念
Professional Competencies
專業(yè)能力： 1. Familiar with electrical and automation principles, understanding of hardware and software design.
熟悉電氣自動化原理，了解軟硬件設(shè)計。
2. Knowledgeable in common of PLC and IPC- Hardware/Software such as STEP7, Portal, Zenon, WinCC.
具備PLC，IPC軟件知識比如：
STEP7，博圖，Zenon, WinCC.
3. Ability to convey concepts and report to different management levels and across functions within the Org.
能夠向組織內(nèi)不同的管理層和不同的職能部門傳達概念和報告。
4. Project management skills. Good understanding of the commissioning and qualification process and activities
項目管理技能。良好的理解調(diào)試和驗證過程與活動
5. 編程語言：掌握 C# 或Python等編程語言，用于數(shù)據(jù)分析或系統(tǒng)集成。 1. Experience in risk assessments such as PFMEA methodology
有風險評價的知識比如使用PFEMA工具
2. Knowledge of Kepware is preferred.
具備Kepware軟件知識最好。
3. Knowledge of IBA is preferred.
具備IBA軟件知識最好。
4.
Leadership Competencies領(lǐng)導能力：
Leadership competencies at proficient level, in line with corporate framework.
參照羅氏集團領(lǐng)導能力標準和要求，領(lǐng)導能力達到熟練水平
Remarks:
備注：
? SHE Responsibility please refer to RDSZ SHE handbook.
安全健康環(huán)保相關(guān)職責：請參照羅氏蘇州安全健康環(huán)保手冊，履行相應安全健康環(huán)保職責
? 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.
技術(shù)、生產(chǎn)和質(zhì)量管理部門崗位任職資格應符合中國醫(yī)療器械GMP 第八章和體外診斷試劑 小節(jié) 2.1.1