- Manages manufacture aspects of BioChina engineering across GMP facilities (USP, DSP, HVAC and clean utility). Manages daily operations of relative systems & equipment, developing and performing Maintenance & Calibration activities, and all associated documentation, to ensure stable and reliable manufacturing whilst maintaining GMP and regulatory requirements.负责管理勃林格殷格翰生物药业(中国)有限公司相关GMP设施(上游工艺,下游工艺,暖通以及洁净工程)相关的所有工程技术事宜。负责洁净相关设备的日常运营,升级,维护及校准工作,并做好相关文档工作,以确保生产稳定可靠运行,同时严格遵守GMP及相关监管要求。
- Possesses excellent process & Utility design knowledge; Acting as lead Engineer, implementing change initiatives through local and global expert input, including associated automation across the entire facility, to budget, time and all quality aspects.具备卓越的工艺&设施设计相关知识;作为主管工程师,贯彻实施本土及国际方面的相关决策输入,包括涵盖所有设施相关自动化;把关成本控制,时间控制及质量控制等各方面。
- Facilitates project manager to execute or support process related Capex projects or interface projects, according to time schedule, budget and quality.根据进度计划、预算、及质量监管等多方面要求协助项目经理以保证工艺相关的资本支出项目或内部项目的顺利进行。
- Continuously improves inter-personnel skills to ensure the above three basic purposes are fulfilled. Capable to lead Internal & External engineering personnel to ensure reliable & efficient operations within GMP BioPharma operations.能够通过不间断的提高自身人际关系以确保实现上述三条基本要求。具备领导内部及外部工程人员的能力以确保对勃林格生物药业生产提供可靠有效的GMP运营维护。
- Provides technical support to other discipline system and equipment in respects to fault finding / diagnostics, and repair. 其他系统设备的故障检测、分析、修护提供相关技术支持。
- Providing Engineering Excellence to User and Operator 为最终用户和操作人员提供卓越的工程支持
- Proactively communicates equipment related bottlenecks or shortcomings to Planning / Engineering Manager in order to avoid lag times主动向工程经理沟通设备相关的瓶颈或缺点,以避免滞后
Keep improving the performance of process/HVAC/CU equipment and system. Provide a stable and reliable system for production.持续改进工艺/暖通/洁净工程设备和系统的性能,为生产提供稳定可靠的系统。
Prepare maintenance / calibration specifications for process/HVAC/CU equipment, including specification of critical spare part management准备工艺/暖通/洁净工程设备的维护/校准规范,包括关键备件的管理规范
Coordinates / Executes maintenance / calibration activities for process/HVAC/CU equipment in consultation with operation and other supporting functions协调/执行工艺/暖通/洁净工程设备的维护/校准活动,并与生产部和其他辅助职能部
Initiates, supervises and coordinates internal and external maintenance / calibration services for process/HVAC/CU equipment组织、监督和协调工艺/暖通/洁净工程设备的内部和外部维护/校准服务
Develops and optimizes process/HVAC/CU equipment/system for BI use开发和优化用于勃林格殷格翰使用的工艺/暖通/洁净工程系统/设备
Be responsible for the whole life cycle of rocess/HVAC/CU equipment/system, including SOP’s负责工艺/暖通/洁净工程系统/设备的整个生命周期,包括其标准操作规程
Be responsible for GMPcompliance of process/HVAC/CU equipment/system as well as associated technical documentation (engineering part). Conduct GMP related Deviations, Investigations, CAPA’s etc as required负责工艺/暖通/洁净工程系统/设备和相关技术文档(工程部分)的GMP合规性。 根据需要发起GMP相关偏差,调查,CAPA等
Ensures EHS compliance is maintained during normal running, and for equipment modifications and new equipment/facilities确保在设备正常运行,维护及更新期间的EHS合规性
Provides overall knowledge of occupational safety and GMP requirements了解并掌握关于职业安全和GMP要求的综合知识
Monitors performance of process/HVAC/CU and relevant automation systems, to ensure reliability and integrity of GMP status. Fault finding where required to overcome problems.关注工艺/暖通/洁净工程和相关自动化系统的运行,确保其GMP状态的可靠性和真实性。在设备故障时进行诊断和处理。
Driving Design and Implementation 驱动项目设计和实施-
Develops reliable and flexible biopharmaceutical process/HVAC/CU system concepts- 针对用于生物制药领域工艺/暖通/洁净工程设备创建可靠及灵活的理念-
Supports qualification activities- 支持验证工作-
Ensures availability and operational readiness of equipment and systems- 确保设备和系统的可用性和运营准备状态-
Leads and coordinates engineering partners on technical topics- 在技术方面领导和协调各方合作伙伴-
Coordinates procurement, design, installation, commissioning activities of equipment and systems协调采购,设计,安装,设备和系统调试活动 -
Provides financial overview and controlling of project scope during project lifetime- 在项目期间提供财务概况和支持财务控制
CapEx Project Planning 投资项目计划-
Supports the Planning, cost calculations & implementation of investment for local and international projects- 支持本地和全球项目的计划,成本核算和执行-
Carries out GMP-compliant technical planning for pharmaceutical facilities in respect to process technlogy.- 在工艺技术方面对制药设施进行符合GMP的技术规划 -
Supports in developing system solutions up to commissioning, qualification and hand-over to the operator/end users- 支持自系统开发的解决方案,包括调试,验证到移交给操作员/最终用户
Continuous Improvements 持续改进 -
Identify improvement potentials and implement all related measures- 识别出潜在可改进的方面并实施相应的措施
Ability to work on a wide spread field of process technologies in GMP-Environment- 在GMP领域具备广博的工艺技术知识 -
Performance focus orientated, persistence in driving solutions and timely decision making- 以绩效为重心,坚持推动解决方案,及时做出决策-
Strategic thinking, economic orientation and business competence in planning and realization of investment projects- 战略思考,经济导向和投资项目规划实现中的业务能力
- Education/Degree Requirements: Bachelor / Master degree in mechanical or Process Engineering 机械工程学或工艺工程学的本科/硕士或者同等学历
- Language skills & proficiency:Good English skills, both written and spoken熟练的英语能力,包括口语和写作
- Required professional certificates / licences:Candidate should offer direct relevant operational experience in process/HVAC/Clean Utility engineering and Operational execution, and project management within a pharmaceutical company候选人应拥有制药公司工艺/暖通/洁净工程,运营保障和项目管理方面的直接相关工作经验
? Work Experience for > 3 years工作经验3年以上? Experience in technical support, project planning and design of process/HVAC/CU equipment in the biopharmaceutical environment生物制药领域的工作经验,包括技术支持,项目计划及工艺/暖通/洁净工程设备的设计
? Experience in maintenance & Calibration of process/HVAC/CU equipment in the biopharmaceutical environment在生物制药领域对工艺/暖通/洁净工程设备维护及校准的工作经验
? Knowledge of occupational safety and GMP职业安全和药品生产质量管理规范的知识
? Experienced user of SAP and MS Office as well as data basesSAP系统,MS office以及数据库的经验丰富
? High level of initiative and flexibility具备很高的创造性和灵活性? Strong planning and organizational skills具有较强的计划和组织能力
? Targeted and autonomous working style目标明确,自主工作能力强
? Routine working with local teams, and collaboration with global experts as required日常本地团队协作及与全球专家的合作能力
? Self-confident, self-motivate and results orientated自信,主动,以结果为导向
? Social competence, customer orientation and a good team player有社会竞争力,有顾客意识,良好的团队合作能力
职能类别: 工程/设备工程师 产品工艺/制程工程师
联系方式
上班地址:上海市浦东新区哈雷路1090号
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