M&S-Area Maintenance Manager-Beijing

Job title职位名称: Area Maintenance Manager

• Location工作地点： Beijing 北京

About the job工作职责

Our Team我们的团队：

Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.

制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

Generic 概述

·        Manage engineering department including activities as maintenance, troubleshooting engineering and technical support. These activities cover all production equipment including solid and sterile, must be performed in compliance with GMP regulations (Good Manufacturing Practices) and Sanofi HSE requirements (Health Safety and Environmental).

管理工程部门维护、故障排除工程和技术支持等活动。这些活动涵盖所有生产设备，包括固体和无菌设备，必须符合GMP法规（良好生产规范）和赛诺菲HSE要求（健康、安全和环境）。

·        Responsible for solid and sterile manufacturing/packaging equipment maintenance and trouble shooting to ensure normal production operation. 

负责固体和无菌生产/包装设备的维护和故障排除，以确保生产正常运行。

·        Develop and ensure that adequate and appropriate procedures and records are maintained and updated to ensure operating success

制定并确保维护和更新充分且适当的程序和记录，以确保运营成功。

·        Ensure that maintenance staff work according to safety rules,cGMP’s as well as to other related laws regulations

确保维护人员按照安全规则、cGMP 以及其他相关法律法规开展工作。

·        To guarantee equipment installation and preventive maintenance. To support qualification and process transfer timely and properly.

保证设备的安装和预防性维护。及时、妥善地支持验证和工艺转移。

·        To plan for and ensure availability of spare parts, and to collaborate in the acquisition process of those parts and maintenance contractors

计划并确保备件的供应，并参与备件和维护承包商的采购流程。

·        To optimise the use of equipment and to provide advice and support to production on maximizing efficiency.

优化设备使用，并为生产部门提供关于提高效率的建议和支持。

·        To prepare budgets and monitor spending accordingly. To assist in the creation of investment plans to ensure all of the above is successfully accomplished.

编制预算并相应地监控支出。协助制定投资计划，以确保以上所有目标的顺利实现。

·        To plan and provide adequate training to the employees reporting to him/her to meet job requirements, including GMP.

计划并为下属员工提供充分的培训，以满足工作要求，包括 GMP 培训。

·        To conduct employee performance appraisal, and ensure development plans are in place for his/her reports.

进行员工绩效考核，并确保其下属制定发展计划。

·        Act as an SME for a Engineering maintenance related discussions during audits/inspections and provide support to Capital Projects as required

在审计/检查期间，作为工程维护相关讨论的专家，并根据需要为资本项目提供支持。

·        Support the initiation, approval and implementation of energy-saving projects, according the energy-saving plan, promote the implementation of energy-saving projects, participate in internal and external audit of energy management systems

根据节能计划，支持节能项目的启动、审批和实施，推动节能项目的实施，并参与能源管理体系的内部和外部审计。

·        Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations

根据现行医疗器械良好供应规范 (GSP) 的规定，开展与医疗器械相关的活动。

·        Ensure all the above tasks are performed / achieved while adhering to Sanofi Values.

确保在履行上述所有职责的同时，始终秉持赛诺菲价值观。

AL9 Project

AL9项目

·        Lead the AL9 Maintenance team（internal or external） and ensure sufficient resources available for commissioning, productioning of AL9 A&P Line based on site needs and strategic workforce planning

主导AL9 维护团队（内部或外部），并根据现场需求和战略性人力资源规划，确保AL9 组装包生产线的所有调试运行活动均有充足的资源。

·        Identify improvement opportunities for critical systems in the project phase

在项目阶段识别关键系统的改进机会

·        Implementing process improvements to enhance efficiency, safety, and quality during the project phase and also routine management

在项目阶段和日常管理中实施流程改进，以提高效率、安全性和质量

·        Participate in applicable commissioning operation procedures

参与与实施调试确认规程的应用

·        Advise on system lifecycle changes, including upgrades, decommissioning, and revalidation requirements.

就系统生命周期变更提供建议，包括升级、退役和重新验证要求

HSE Responsibility

安全职责：

·        everyone is responsible for HSE, each staff and workers should be in their respective posts, conscientiously perform their duties, do a good job of their own work, the safe production of their post is directly responsible.

HSE人人有责, 每个职工都应在各自的岗位上, 认真履行职责, 做好本职工作, 对本岗位的安全生产负直接责任。

·        Careful care and correct use of machinery, equipment, tools and labor protection supplies, finished products, semi-finished products, materials and waste should be stacked in a designated area, to maintain a clean working environment, shall not affect the operation and passage of personnel.

精心爱护和正确使用机器、设备、工具及劳动保护用品, 成品、半成品、物料及废物等须堆放在指定区域, 保持作业环境整洁, 不得影响人员操作和通行。

·        Check the safety of machines, equipment, tools, electricity and working environment before and during class to prevent dangerous situations such as running, dripping and leaking. Find unsafe factors to deal with in time or report to leaders.

班前、班中须检查机器、设备、工具、电气及作业环境的安全情况, 防止跑、冒、滴、漏等危险情况的发生。发现不安全因素及时处理或向领导汇报。

·        Careful implementation of the succession system, the succession must be carefully checked before the position of equipment and safety facilities are intact.

认真执行交接班制度，接班前必须认真检查本岗位的设备和安全设施是否齐全完好。

·        Comply with HSE rules and regulations and obey management.

遵守HSE规章制度和操作规程，服从管理。

·        Correct wear and use of labour protective equipment.

正确佩戴和使用劳动防护用品。

·        Accept HSE education and training, participate in emergency drills, master the safety knowledge needed by their work, improve safety prevention skills, enhance accident prevention and emergency response capabilities.

接受HSE教育和培训，参加应急演练，掌握本职工作所需的安全知识，提高安全防范技能，增强事故预防和应急处理能力。

·        If any hidden danger or unsafe factor is found, it shall immediately report to the HSE management personnel or the person in charge of the company.

发现事故隐患或者不安全因素，应当立即向现场HSE管理人员或者公司负责人报告。

·        Participate in the daily + QDCI meeting, in accordance with the requirements of HSE8, fill in and feedback all kinds of HSE problems timely and correctly, and actively implement rectification.

参加每天+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。

·        When a production safety accident emergent, it will obey the unified command at the scene.

发生生产安全事故紧急撤离时，服从现场统一指挥。

·        Comply with accident investigation and provide relevant information faithfully.

配合事故调查，如实提供有关情况。

·        Those who engage in special operations are specially trained to get special assignments.

从事特种作业的，经过专门培训取得特种作业资格。

·        Occupational health qualifications: Occupational disease protection equipment and occupational disease protection articles for personal use should be regularly maintained and overhauled, their performance and effect should be regularly tested to ensure that they are in a normal state and may not be dismantled or stopped using without authorization. Learn and master the relevant occupational health knowledge, abide by the laws, regulations, rules and operating rules of occupational disease prevention and control, correctly use and maintain occupational disease protection equipment and occupational disease protection articles for personal use.

职业健康资格：对职业病防护设备和个人使用的职业病防护用品，应当进行经常性的维护、检修，定期检测其性能和效果，确保其处于正常状态，不得擅自拆除或者停止使用。 应当学习和掌握相关的职业卫生知识，遵守职业病防治法律、法规、规章和操作规程，正确使用、维护职业病防护设备和个人使用的职业病防护用品。

Quality requirements

质量要求

·        Report product complaints and adverse drug reactions according SOP requirements.

根据SOP要求报告产品投诉和药物不良反应。

·        Participate in and complete personal training on time.

按时参加并完成个人培训。

·        Operate in accordance with SOP standards.

按照SOP标准要求进行操作。

·        Fill in GMP documents and records in accordance with SOP standards.

按照SOP要求填写GMP文件和记录。

·        Report abnormal conditions in a timely manner.

及时汇报异常情况。

·        Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations.

依据现行经营管理规范（GSP）执行医疗器械相关活动”

About you 任职资格:

• Minimum of a Bachelor’s Degree in automation / mechanical technology, automation instrumentation or similar disciplines, or equivalent work experience.

自动化、机械、自动化仪器仪表或相关专业，本科及以上学历。

• Previously worked at MNC company and is familiar with Assembling & packaging equipment and processes.

就职于MNC公司，并熟悉组包装设备及其工艺

• Strong People Management skills and demonstrated ability to work with cross functional teams.

具备出色的人员管理技能和与跨职能团队合作的能力。

• Good manipulative ability, strong sense of responsibility, good teamwork and communication ability, can solve the problem occurred during the work independently.

良好动手能力,责任心强,良好的团队合作和沟通能力,可以在工作中独立解决问题。

• Knowledge of GMP regulatory requirements for activities and be able to defend and justify CQ plans and practices during internal/external audits.

了解 CQ 活动的 GMP 法规要求，并能够在内部/外部审计期间为 CQ 计划和实践进行审计回复及证明。

• Languages: Good English writing and communication skills, technical writing and investigation techniques

语言要求: 良好的英语书写及沟通能力并具备调查分析技巧

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。