Engineer, Operation & Maintenance /运行维护工程师 苏州

月薪： 1.5千以下/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： SUMMARY 概述Full time operation and maintenance for the equipment and facilities of the global-standard CMAB in Suzhou:全职负责苏桥医药公司在苏州工厂设备设施的运行及维护:？Active participation in the development and implementation of the Company Quality Management System with specific responsibility for facility systems and critical equipment: routine operation and maintenance and response to breakdown maintenance.参与开发和实施公司以及部门的质量管理系统，厂务和关键设备的常规维护和应急维修。？Ensuring the Company’s direct-impact equipment are maintained in a validated state.确保公司核心的自动化系统的维护在验证状态？Management of specialist contractors and vendors to maintain equipment.管理专业承包商和供应商对设备进行维护。？First point of call for the Company’s facility systems including:公司设施的服务响应：？Bioprocessing equipment/ 生物工艺设备？Process Development equipment/ 工艺开发设备？HVAC (Classified Cleanrooms and general areas)/ 空调(分级的洁净车间及普通区域)？Water system (PW, High PW, WFI)/水系统(纯水，超纯水，注射用水)？Pure Steam System/ 纯蒸汽系统？Compressor Dry Air system/ 空压机及气体干燥系统？Special gas distribution & station systems/ 特气站及分配系统？Temperature control units/ 温度控制单元？Chilled water system/ 冷冻水系统？Cooling water system/ 冷却水系统？Boiler system/ 热水系统？Vacuum drain system/ 真空排水系统？Waste Water system/ 废水系统？Electrical power system (including UPS and emergency generator)/ 供电系统(包含应急电源及应急发电机)SUMMARY 概述Full time operation and maintenance for the equipment and facilities of the global-standard CMAB in Suzhou:全职负责苏桥医药公司在苏州工厂设备设施的运行及维护:？Active participation in the development and implementation of the Company Quality Management System with specific responsibility for facility systems and critical equipment: routine operation and maintenance and response to breakdown maintenance.参与开发和实施公司以及部门的质量管理系统，厂务和关键设备的常规维护和应急维修。？Ensuring the Company’s direct-impact equipment are maintained in a validated state.确保公司核心的自动化系统的维护在验证状态？Management of specialist contractors and vendors to maintain equipment.管理专业承包商和供应商对设备进行维护。？First point of call for the Company’s facility systems including:公司设施的服务响应：？Bioprocessing equipment/ 生物工艺设备？Process Development equipment/ 工艺开发设备？HVAC (Classified Cleanrooms and general areas)/ 空调(分级的洁净车间及普通区域)？Water system (PW, High PW, WFI)/水系统(纯水，超纯水，注射用水)？Pure Steam System/ 纯蒸汽系统？Compressor Dry Air system/ 空压机及气体干燥系统？Special gas distribution & station systems/ 特气站及分配系统？Temperature control units/ 温度控制单元？Chilled water system/ 冷冻水系统？Cooling water system/ 冷却水系统？Boiler system/ 热水系统？Vacuum drain system/ 真空排水系统？Waste Water system/ 废水系统？Electrical power system (including UPS and emergency generator)/ 供电系统(包含应急电源及应急发电机)ESSENTIAL FUNCTIONS 主要职责Essential functions include, but are not limited to the following:主要职责包括但不限于：？Site Safety/ 厂区安全？Contributing to the safe operation of CMAB facilities through personal initiative and adherence with Company procedures.主动积极并遵循公司政策流程确保公司设施安全运行？Zero lost-time injuries实现零损失工时事故？Maintenance of Facility Systems/ 设施系统维护？Maintaining the operational state of facility systems incompliance with Good Manufacturing Practice (GMP).按照GMP规范，维护设备系统的运作状态？Coordination of specialist service providers and vendors to execute the maintenance program.协调供应商承包商执行安全程序。？Breakdown repair and trouble-shooting of equipment and facilities.设施设备的故障诊断和应急维修？On call (SMS) for emergency response to system alarms.实时响应系统报警？Replacement of parts to keep facility normal operation更换备件，保证设施正常运行。？Annual, half year, quarterly, monthly, weekly maintenance of facility systems.设施系统的年度，半年，季度，月度及周维护？Managing inventory of critical spare parts for facility systems and critical instruments.管理设施系统和关健仪表的关健备品备件库存。？Minor redesign and capital projects to improve operation status.微小的重新设计及资产项目提升运行稳定性。？Quality/ 质量？Preparing standard operating procedures and associated records for management and execution of the maintenance program.制定操作规程，管理相关记录，执行维修程序？Complying with, and continuously improving, the Company Quality Management System.遵循并不断改进公司的质量管理系统？Design/ 设计？Review and mark-up of design drawings to provide practical and easily maintained design.审核，标注设计图纸，提供实际，易维护的设计。？Recommend and approve preferred vendors for equipment and spares.推荐及批准设备备件的推荐供应商？Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.选择关键和常规的维修备件，例如气体过滤器，高效过滤器，电机，电器，化学消耗品QUALIFICATIONS (EDUCATION, CERTIFICATIONS, EXPERIENCE) 任职资格(教育，证书及经验)？B.E. (preferably Electrical power or mechanical) plus a minimum of 2 years responsibility facility systems within pharmaceutical organization本科(电气或机械专业优先)+至少2年药厂设施经验？Or at least 5 years facility maintenance experience in healthcare, specialty chemicals, FAB, or food industries.或至少5年药厂设施经验，或者8年医疗，化学，食品行业设施经验。？Detailed knowledge and hands-on experience in maintenance of facility systems.有维护设备系统的知识和实际操作经验？Preferably experienced in operation of biopharmaceutical API facilities and/or aseptic fill-finish and exposure to facility start-up.有生物制药原料设施和/或灌装或建厂经验的优先考虑OTHER KNOWLEDGE AND SKILLS REQUIRED:/ 其它知识及技能需求？Sound knowledge of Good Engineering Practices encompassing documentation and equipment selection for pharmaceutical facilities.理解GEP工程实践如制药厂设施选型，文档管理？Sound Understanding of Good Manufacturing Practice (GMP)理解GMP？Experienced in operation and optimization of facility systems.设施系统运行改进的经验？Advanced hands-on skills in maintenance of equipment and replacement of spare parts.熟练的设备动手维护能力及备件更换能力。？Ability to investigate and solve problems.有故障调查及问题解决能力？Prefer to have Licenses for facilities operation such as: Low voltage, pressure vessel, boiler attendant, forklift operation, safety operation.有以下设施运行证书优先:低压电工证，压力容器操作证，锅炉操作证，铲车操作证，安全操作证等。？Qualified in CPR会实施心肺复苏等急救措施？Stand by on holiday and midnight 24hours 365days operation facility system关注全时段的设施运行情况，包括节假日及晚上。？Experience with facility monitoring systems (prefer Siemens)设施监控系统经验（西门子优先）？Familiar with maintenance of automated systems including Siemens PLCs熟悉自动化系统维护，包含西门子PLC.？Sound communication skills in English and Chinese to engage with personnel across the Company and service providers including writing technical documentation in English.中英文沟通能力强，激励周围人，理解英文技术文件。 职能类别： 工程/设备工程师 生物工程/生物制药 关键字： 运维工程师

联系方式

东平街188号

公司信息

苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。

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