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2 months ago
岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Provide routine Production Equipment maintenance service for BSuB site.
为梅里埃(苏州)生物制品有限公司提供生产设备的日常维护工作。
Organize and coordinate the assigned work and provide efficient and cost effective Operation and maintenance services.
把分配到的工作进行组织和协调,提供高效率和低成本的运营、维护服务。
Set up and maintain the operation & maintenance management system for production equipment and make sure that all Biomerieux Global directives, GEP (Good Engineering Practice) and GMP are fully implemented.
对生产设备建立运行维护的管理系统,保证梅里埃总部的指导, GEP 和GMP 规范得到有效贯彻。
主要职责 / MAIN ACCOUNTABILITIES
Safety, Health & Environment /安全,卫生和安全
Learn, master, and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.
学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准,履行法规要求的HSE责任和义务。
Strictly comply with HSE rules and regulations and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely.
严格遵守公司HSE规章制度,服从公司的HSE管理,并执行本岗位的HSE管理要求,承诺“不伤害自己、不伤害他人、不被他人伤害,保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。
Quality and Compliance /质量和法规符合
Collaborate with site quality to make sure Right to operate through compliant to all related regulatory requirements.
和本地质量相关部门合作,确保所有操作满足相关质量法规要求。
Implement and apply the Biomerieux Quality System.
执行并应用梅里埃质量管理系统。
Cost Management /成本控制
Support line manager to control team expenses within the set year budget.
协助直线经理按预算目标管理并控制花费支出。
Seek continuous improvement opportunities to decrease the operation, maintenance cost and energy cost within owned area .
在管辖系统领域寻找持续改进方法,降低运行和维护成本以及能源成本。
Routine Operation /日常运营
Responsible for the Maintenance of all production equipment –including but not limited to Weighing system, Formulation system, CIP system, COP system, Filling lines, Mixed Gas system,Autoclave system, Packaging Lines, Forklift, , etc.
负责厂区所有生产设备系统的维护工作- 包括但不限于以下系统:称量系统、配液系统、在线清洗系统、离线清洗系统、灌装线系统、混合气体系统、灭菌釜系统、包装系统、叉车等。
Evaluate system performance and develop related actions to improve system operational & maintenance & Energy efficiency.
评估系统的性能并采取相关的行动来提高系统的运行、维护及能源效率。
Ensure in time response to critical alarms in compliance with the SOP and related Quality Procedures.
确保及时响应关键报警以符合SOP及相关质量程序。
Optimize or upgrade related systems to meet company strategy and/or system requirement.
根据公司策略或者自身系统的需要对相关系统进行优化或改造。
Other tasks assigned by line manager.
直线经理指派的其他任务。
知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
College degree (equivalent) or above.
大专及以上学历。
Be familiar with relative medical device regulation or codes, such as ISO 9001, ISO 13485 and GMP
熟悉ISO 9001, ISO 13485 和GMP等医疗器械相关的法规规范
Language skills: Basic for Listening, Speaking, Reading and Writing of both English.
语言:基础的英语听、说、读、写能力。
Chemical Engineering, Pharmaceutical Engineering, Mechanical related background with no less than 5 years of Plant production maintenance experience in IVD or pharmaceutical industry. Familiar with the maintenance of Weighing system, Formulation system, CIP system, COP system, Filling lines, Mixed Gas system,Autoclave system, Packaging Lines, etc.
化工、制药、机械等相关专业背景,并具有5年以上体外诊断或制药行业工厂生产设备维护经验。熟悉称量系统、配液系统、在线清洗系统、离线清洗系统、灌装线系统、混合气体系统、灭菌釜系统、包装系统等的日常维护工作。
Independent technical knowledge regarding to the Preventative and Re-active maintenance, troubleshooting of site production equipment.
具有独立的生产设备预防性和应急性维护,故障排除的技术能力。
Prefer to have the Electrician Certificate.
具有电工操作证的优先。
Experience and Capability in GMP related equipment commissioning, qualification and validation process.
具有GMP相关设备调试,确认和验证流程方面的经验和能力。