M&S-Associate Engineer, Inoculation-Shenzhen

Job Information 职位信息

Job title职位名称:Associate Engineer, Inoculation 接种助理工程师

• Location工作地点： Shenzhen, Guandong Province, China 中国广东省深圳市

• % Remote working and % of travel expected 远程办公和出差的概率：N/A

• Job type工作类型: Full time全职

• Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部

About the job 工作职责

Our Team 我们的团队：

The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.

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。

• Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.确保赛诺菲在中国运营的所有产品的分销和营销活动符合赛诺菲质量政策、质量标准及适用的法规要求。

• Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.管理质量流程并执行程序中定义的质量控制活动，特别是根据现行GSP/GDP法规建立的相关活动。

• Provide strong quality support to innovation and business initiatives, including digital transformation projects. 从质量角度为创新和业务举措（包括数字化转型项目）提供有力支持。

• Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements. 在整个组织中推广质量文化和质量思维，确保符合赛诺菲全球标准和中国本地法规要求。

Main responsibilities 职责描述：

1. Team management and Personal development 团队管理及人员发展

• Pay attention to health,safety and production environment requirements, and improve and adjust accordingly if necessary

• 关注健康、安全及生产环境要求并在必要时做出相应改善及调整。

• Responsible for the inoculation steps in the production of influenza stock solution, and complete all related operations of virus inoculation preparation, inoculation and cultivation. Then the inoculated chicken embryos and eggs are cultured to multiply the virus and delivered to the harvesting group; daily cleaning and disinfection, material preparation and environmental monitoring are carried out. Comply with quality and health, safety and environment regulations in production operations, ensure safe and effective production operations, and provide technical support to the team and other departments.

• 负责流感原液生产的接种步骤，完成病毒接种液的制备、接种和培养的所有相关操作。然后将已完成接种的鸡胚蛋经过培养使病毒增殖交付到收获组；并进行日常清洁消毒、物料准备和环境监控等。在生产操作中遵守质量及健康安全环境守则，确保安全有效地进行生产操作，为团队及其他部门提供技术支持。

2. Work Delivery 工作交付

• Ensure staff training and qualification according to the requirements; Ensure the supply of material and manpower deployment；

• 根据要求确保个人的培训及资质；确保物料供应；

• Participate in the production operation of the inoculation process, ensure safe, compliant, and effective production operations, and deliver products on time, quality and quantity;

• 参与接种工序的生产操作，确保安全、合规、有效地进行生产操作，并按时按质按量交付产品；

• Ensure production activities according to related procedure, standard operating procedures and batch records, supervision and inspection records of area.

• 确保生产活动根据相关工艺规程、标准操作规程及批记录进行，按时填写和提交区域记录和批记录。

• Ensure data integrity in production activities meets requirements;

• 确保生产活动中的数据完整性符合要求；

• Participate in the writing and execution of all validation plans/reports in this group.

• 参与本组所有验证方案/报告的编写和验证的执行。

• Provide/enter relevant production data (MES, SAP, CMS, One LIMS,SMS2.0, SPCetc.) on time;

• 按时提供/录入相关生产数据 (MES, SAP, CMS ,One LIMS,SMS2.0，SPC等)；

• Timely report and assist in resolving issues that arise during production; Responsible for writing relevant technical documents; Participate in investigating deviations that occur in the production field; Timely completion of CAPA;

• 及时汇报并协助解决生产中出现的问题；负责相关技术文件的编写；参与调查生产领域中发生的偏差；及时完成CAPA；

• Responsible for receiving production materials and solution containers in the vaccination area, ensuring the supply of production materials, following up on non BOM material inventory, and timely applying for procurement.

• 负责接种区域生产物料，溶液容器具的领用，确保生产物料供应，跟进非BOM物料库存情况，及时申请采购。

• Lead and train new employees, and ensure that new employees are qualified for on-the-job operation.

• 带领和培训新员工，保证新员工培训合格后上岗操作。

3. Quality system implementation 质量系统实施

• Handling and investigating deviations in the production field; Propose evaluation and change control based on the actual situation, and timely complete the CAPA.

• 处理、调查生产领域中发生的偏差；根据实际情况提出评估处理变更控制，及时完成CAPA。

• With the assistance of relevant departments and continuous improvement teams, complete the required calibration/validation/validation activities for the machine/equipment/plant on time.

• 在相关部门和持续改进组的协助下，按时完成规定的机器/设备/厂房的校准/确认/验证活动。

• Actively participate in workshop GMP self inspection to promote departmental GMP compliance. Supervise and urge the workshop to continuously improve.

• 积极参与车间GMP自查，促进部门GMP合规性，督促车间持续改进。

• Undertake the relevant authorization responsibilities of the inoculation supervisor of the bulk production department, and review and sign GMP related documents.

• 承担原液生产部接种主管的相关授权职责，进行GMP相关文件审核和签名。

• Deliver specified continuous improvement projects or other work objectives.

• 交付指定的持续改进项目或其他工作目标。

4. Goal realization, the implementation of company values and culture 实现目标、实施公司价值观和文化

• Achieve departmental goals, conduct regular reviews to achieve the company's development direction.

• 达成部门目标，定期进行回顾，以实现公司发展方向。

• Strengthen communication and cohesion within the department and across departments, to ensure the achievement of work objectives and maximum efficiency.

• 加强部门内部及跨部门沟通和凝聚力，以保证达到工作目标和最高工作效率。

• Take the Lead Value: Aim Higher; Act for Patients; Be Bold; Lead Together.

• 敢为人先价值观: 志存高远, 心系患者, 敢于创新, 聚力同行

• Obey the work arrangement of the department or the direct superior, and actively participate in the backup and transfer of different positions.

• 服从部门或直接上级工作安排，积极参与不同岗位的备份和转岗工作。

About you 任职资格:

Experience:

• 工作经验: 3年以上药企相关工作经验。

Soft skill:

• 通用技能: 会操作办公软件，如word、Excel、Powerpoint。具有团队领导能力、横向合作和良好沟通能力。

Technical skill:

• 专业技能: 熟悉制药法规，如GMP、药典。熟练撰写文档、流程和指引，会运用风险分析方法。

Education:

• 教育背景:全日制专科以上学历, 熟悉生物化学、微生物学、病毒学、物理化学知识；

Language requirement: Good proficiency in both Chinese and English languages

• 语言要求：良好的中文和英语语言能力

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。

Take The Lead Behaviours：Aim Higher、Act for Patients、Be Bold and Lead Together

引领前行行为：更高目标、以患者为本、勇于创新、共同领导

Pursueprogress, discoverextraordinary

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, ability or gender identity.

Watch ourALL IN video and check out our Diversity Equity and Inclusion actions atsanofi.com!