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 mechanical 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机械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 GEP, GMP and Roche standards 依据GEP,GMP以及罗氏标准
Cooperate to Develop the User Requirements Specifications, technical specification etc documents
协作编写用户需求,技术规格等文件
Technical clarification on the quotation, sufficient mechanical component spare parts list and all related P&ID, drawings with the vendor
对供应商的报价、机械部件必备备件清单P&ID以及相关图纸的技术澄清
Supervising execution equipment /System Installation & commissioning according to the GEP and GMP监督设备/系统安装调试过程中的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 :
?Mechanical Bachelor degree holder (equivalent) or above 机械专业学士学位或以上
Language skills语言能力:
- Understand the professional documentation (P&ID, Functional Specification, etc.) in English 理解英语撰写的专业文件(P&ID, 功能规范说明书等)
- 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：
- AutoCAD for 2D and software for 3D is preferable. 用于2D 的AutoCAD, 3D软件更佳。
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：
- Mechanical engineering, Installation & commissioning, and project execution for Pharmaceutical Industry. 服务于制药领域的机械工程、安装调试以及项目执行。
- Must be familiar with ASME, ATEX, ISO, EN, DIN, GB Code relevant to Mechanical design and authority regulations 熟悉ASME, ATEX, ISO, EN, DIN, GB等相关机械设计规范以及相关监管机构法规。
- Knowledge in pharmaceutical solids manufacturing with high containment and WIP/CIP technology. 高防护隔离以及WIP/CIP技术在固体制药生产中运用的相关知识
- Maintenance or Mechanical design experience in Pharma are preferable 制药领域维护或者机械设计经验者优先
Familiar with FDA, EMA and Chinese cGMP requirements 熟悉FDA, EMA 以及中国cGMP 要求
Technical knowledge regarding the design, operation, preventative maintenance of manufacturing processes and equipment is required. 具备生产工艺以及设备所需的设计、运行、预防性维护等技术知识
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
Experience in equipment installation and commissioning programs are required. 具有设备安装、调试经验
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。