北京招聘

Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）
Responsible for create all requirements and related deliverables on the electrical and automation parts from the user point of view to guarantee the high quality and reliability of process equipments for solid dosage form production.
旨在确保高质量、可靠的固体制剂生产用的工艺设备的目的，负责项目中从用户角度提出与电气自动部分的需求以及相关交付文件。
Assist the Project Manager to successfully plan and execute the projects in each project phases.
协助项目经理顺利计划和执行项目各阶段的执行
Reviews all critical design deliverables in the each project design and execution phases (PI, CD, BD, DD, installation & Commissioning and qualification)
审核项目各阶段中关键的设计交付文件。
Assist project from hand-over to Performance Qualification (PQ), Process Validation, operational start-up, and facility operation
协助项目的PQ阶段的交接，以及后期的工艺验证，运行启动以及运行

Principle Roles & Responsibilities / Accountabilities 主要职责/责任
Responsible for project as a user 实施工程部各类项目
Following GAMP, GEP, GMP and Roche standards 依据GAMP, GEP,GMP以及罗氏标准
Cooperate to Develop the User Requirements Specifications and all related deliverables
协作编写用户需求等相关的交付文件
Technical clarification on the quotation, sufficient electrical component spare parts list and all related HDS, SDS and wiring diagrams, pneumatic diagram, 21CFR part 11with the vendor
与供应商针对报价, 电气部件必备备件清单以及相关接线图、气动图、硬件以及软件设计规范, 21CFR part 11等相关给予技术澄清
Supervising execution equipment /System Installation, cabling , loop tests & commissioning(including system integration, configuration and testing) according to the GAMP, GEP and GMP监督设备/系统安装,接线,回路测试以及调试(系统整合，配置以及测试)过程中的GAMP, GMP以及GEP状况。
Assist in facility maintenance and Support case studies and investigation on trouble shooting 协助公司设施的维护以及协助案例分析和调查
Support coordination with vendors and contractors 协助协调供应商和承包商
Support establishing SOPs 协助建立SOP

Qualification and Experience 能力与经验
1 Education/Qualifications教育程度/所获资格证书
Academic requirement学历要求 :
?Electrical Bachelor degree holder (equivalent) or above 电气专业学士学位或以上
Low voltage operation certificate 低压上岗证
Language skills语言能力:
- Familiar with the professional documentation (HDS, SDS etc.) in English 熟悉英语撰写的专业文件(硬件以及软件设计规范等)
- Chinese, English on brief negotiation level 具有初步谈判级别的汉语，英语水平
Software skills 软件能力：
- Basic SIMENS PLC programing and diagnosis on the I/O. 基本的SIMENS PLC编程以及 I/O诊断 。
- Basic knowledge of AUTOCAD 基本的AUTOCAD运用
2 Leadership Competencies领导者胜任力
Shows a high level of passion and engagement激情并敬业
Integrity倡导诚信
Align for success 协力成功
Learn for the future 不断学习
Able to energize, engage and inspire others 鼓励并激励员工
Deliver results 结果导向
3 Job Required Competencies岗位所需胜任力
Minimum 5 years’ working experience in 至少5年的工作经验：
- Electrical engineering, Installation & commissioning, and project execution for Pharmaceutical Industry. 服务于制药领域的电气安装调试以及项目执行。
- High, low voltage distribution knowledge and maintenance experience良好的高低压配电知识和维护经验
- Familiar with PLC automation system and with basic instrument , sensor and IT knowledge熟悉PLC自动化系统并具有良好的仪器仪表,传感器以及IT知识
Must be familiar with GAMP5, 21 CFR Part 11 ERES, ATEX, ISO, EN, DIN, GB Code relevant to Electrical & Automation design and authority regulations 熟悉GAMP5, 21 CFR Part 11 ERES, ATEX, ISO, EN, DIN, GB等相关电气以及自动化设计规范以及相关监管机构法规。
Electrical & Automation Knowledge in pharmaceutical solids manufacturing with high containment and WIP/CIP technology. 高防护隔离以及WIP/CIP技术设计的电气以及自动化知识在固体制药生产中的运用
Familiar with FDA, EMA and Chinese cGMP requirements 熟悉FDA, EMA 以及中国cGMP 要求
Electrical & automation knowledge regarding the design, operation, preventative maintenance of pharmaceutical manufacturing processes and equipment is required. 具备制药生产工艺以及设备所需的设计、运行、预防性维护相关的电气以及自动化知识
Must have demonstrated ability to solve certain technical problems and ability to work independently具备解决技术问题以及独立工作的能力
Must have excellent organizational, communication and writing skills必须具备组织协调以及写作能力

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。