Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden

Job title职位名称: Process and C&Q Engineer 工艺工程师

• Location工作地点： 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。

Take the lead: Aim higher, act for patients, be bold, lead together

敢为人先：志存高远，心系患者，敢于创新，聚力同行

Main responsibilities职责描述：

• Lead the AL9 Process, plant & CQ team（internal or external） and ensure sufficient resources available for all process, plant & CQ activities of AL9 A&P Line based on site needs and strategic workforce planning

主导AL9 组包装线工艺,调试与确认团队（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工艺、装置和调试与确认活动均有充足的资源。

• Develop and execute equipment validation protocols (IQ/OQ), leads investigations & develops CAPAs for unplanned disruptions, breakdowns and deviations of Process related
• 编制并执行设备验证方案(IQ/OQ),主导调查并制定针对工艺相关意外中断、故障和偏差的纠正和预防措施 (CAPA)
• 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

• Act as an SME for a quality related discussions during audits/inspections and provide support to Capital Projects as required

在审计/检查期间，作为质量相关讨论的专家，并根据需要为资本项目提供支持。

• 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

• Ensure CQ standards are in compliance with regulatory requirements

确保 CQ 标准符合法规要求

• Provide input on resource allocation, budget for process, plant and CQ activities, and timelines for CQ activities
• 为工艺、工厂和调试与确认活动的资源分配、预算以及试与确认活动的计划提供意见
• 全流程管理AL9 组包装线调试确认工作，包括URS,FAT,SAT,IO/OQ/PQ等
• 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。

• Energy saving General：
  • Support the development of energy-saving projects and give positive feedback.

支持节能项目的制定，积极反馈意见。

• Participate in and implement energy-saving projects.

参与并实施节能项目。

• Participate in and implement ISO50001 qualify.

参与并实施ISO50001认证

• Quality requirements
  • 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 CQ 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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

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Pursue Progress. Discovery Extraordinary.

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