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Position : Sr Automation Engineer(BMS)
職位：高級(jí)自動(dòng)化工程師（樓宇自控方向） BA / Dept. :
部門： 綜合服務(wù)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(jìn)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(duì)自動(dòng)化控制技術(shù)的精湛應(yīng)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(jī)組）、FCU（風(fēng)機(jī)盤管）和FFU（風(fēng)機(jī)過濾單元）等關(guān)鍵設(shè)備的運(yùn)行邏輯。將主導(dǎo)西門子 Desigo CC 樓宇管理系統(tǒng)(BMS)的應(yīng)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(yán)格法規(guī)要求的關(guān)鍵人物。
Main Tasks & Responsibilities主要工作職責(zé) :
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(shí)現(xiàn)潔凈室壓差梯度的穩(wěn)定控制，確保不同潔凈級(jí)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(duì)MAU（組合式空調(diào)機(jī)組）、FCU（風(fēng)機(jī)盤管）、FFU（風(fēng)機(jī)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(yùn)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(fēng)量(VAV)系統(tǒng)算法，以達(dá)到精準(zhǔn)控制與節(jié)能的雙重目標(biāo)。
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(duì)PXC系列等控制器進(jìn)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(yīng)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(fù)責(zé)其圖形界面、報(bào)警管理、歷史趨勢及報(bào)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(hù)，熟練使用TIA Portal (博圖) 軟件。
9. Compliance and Validation
合規(guī)與驗(yàn)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(dǎo)所有BMS與HVAC自控相關(guān)項(xiàng)目的驗(yàn)證活動(dòng) (FAT/SAT/IQ/OQ/PQ)，并負(fù)責(zé)編寫和審核關(guān)鍵技術(shù)與驗(yàn)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(yán)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(yīng)用根本原因分析方法論，解決復(fù)雜的潔凈室環(huán)境控制難題，如壓差波動(dòng)、溫濕度超標(biāo)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(shí)施對(duì)HVAC自-控系統(tǒng)的改進(jìn)機(jī)會(huì)，提升系統(tǒng)穩(wěn)定性和運(yùn)行效率。
15. Other tasks as assigned by the head of the department.
部門領(lǐng)導(dǎo)分配的另外的任務(wù)。
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(dòng)化、暖通、機(jī)電一體化相關(guān)專業(yè)，本科及以上學(xué)歷 Bachelor or above education background
本科以上學(xué)歷
Qualification & Certification
資質(zhì)證書 Electrical and Automation education or equivalent by experience
電氣及自動(dòng)化教育或同等學(xué)歷 Bachelor or above degree in Electrical and Automation or equivalent by experience
電氣及自動(dòng)化專業(yè)本科以上學(xué)歷或同等學(xué)歷
Experience
工作經(jīng)驗(yàn): 1. > 5 years working experience
in a high regulated manufacturing site
5年以上工作經(jīng)驗(yàn)或者更高級(jí)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(dú)立完成公用工程PLC項(xiàng)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(tái)：具備對(duì)西門子 Desigo CC從前端到后端的深度技術(shù)理解和豐富的項(xiàng)目實(shí)施/維護(hù)經(jīng)驗(yàn)。
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(dòng)化相關(guān)工作經(jīng)驗(yàn)，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(xiàng)目的設(shè)計(jì)或運(yùn)維經(jīng)驗(yàn)
2. New equipment qualification and validation experience is a plus
有新設(shè)備驗(yàn)證或認(rèn)證的經(jīng)驗(yàn)更好
3. Experience in a highly regulated cGMP manufacturing environment.
具備生產(chǎn)工廠cGMP經(jīng)驗(yàn)
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(dòng)化原理，了解軟硬件設(shè)計(jì)。
2. Knowledgeable in common of PLC and IPC- Hardware/Software such as STEP7, Portal, Zenon, WinCC.
具備PLC，IPC軟件知識(shí)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(dá)概念和報(bào)告。
4. Project management skills. Good understanding of the commissioning and qualification process and activities
項(xiàng)目管理技能。良好的理解調(diào)試和驗(yàn)證過程與活動(dòng)
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(fēng)險(xiǎn)評(píng)價(jià)的知識(shí)比如使用PFEMA工具
2. Knowledge of Kepware is preferred.
具備Kepware軟件知識(shí)最好。
3. Knowledge of IBA is preferred.
具備IBA軟件知識(shí)最好。
4.
Leadership Competencies領(lǐng)導(dǎo)能力：
Leadership competencies at proficient level, in line with corporate framework.
參照羅氏集團(tuán)領(lǐng)導(dǎo)能力標(biāo)準(zhǔn)和要求，領(lǐng)導(dǎo)能力達(dá)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(zé)：請(qǐng)參照羅氏蘇州安全健康環(huán)保手冊(cè)，履行相應(yīng)安全健康環(huán)保職責(zé)
? 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(yīng)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