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： 深圳
• % Remote working and % of travel expected 远程办公和出差的概率：NA
• Job type工作类型:Full time全职
• Site/Unit 区域/事业部：深圳工厂/原液生产部

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。

Main responsibilities职责描述：

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。

Key Accountability 关键职责：

1、Work delivery工作交付

• Ensure staff training and qualification according to the requirements; Ensure the supply of material and manpower deployment；
• Participate in the production operation of the inoculation process, ensure safe, compliant, and effective production operations, and deliver products on time, quality and quantity;
• Ensure production activities according to related procedure, standard operating procedures and batch records, supervision and inspection records of area.
• Ensure data integrity in production activities meets requirements;
• Participate in the writing and execution of all validation plans/reports in this group.
• 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;
• 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;
• 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.
• 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.

2、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.
• 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.
• 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.
• 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.
• GMP相关文件审核和签名。
• Deliver specified continuous improvement projects or other work objectives.

3、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.
• Strengthen communication and cohesion within the department and across departments, to ensure the achievement of work objectives and maximum efficiency.
• Recognize the company culture,Take the Lead (Aim Higher, Act for Patients, Be Bold, and Lead Together).
• (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.

4、People training & development 人员发展

• Pay attention to health, safety and production environment requirements, and improve and adjust accordingly if necessary
• Continuously improve the ability of production personnrl on production ability, deviation handling,change control, environmental monitoring, qualification and validation, HSE and etc;
• HSE等方面的能力。
• Develop cross jobs and multi-skills talent training.

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:高中或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；

• Languages:

语言要求:英语

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。