M&S-Associate Engineer, Harvest-Shenzhen

Job Information职位信息

Job title职位名称: Associate Engineer, Harvest收获助理工程师

• Location工作地点： Shenzhen
• Remote working and % of travel expected 远程办公和出差的概率：0
• Job type工作类型: Full time全职
• Site/Unit 区域/事业部：Shenzhen Bulk Production

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：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

个人发展Personal Development

• 关注健康、安全及生产环境要求并在必要时作出相应改善及调整；

Focus on health, safety and environmental requirement of production, and make corresponding improvement and adjustment when necessary.

• 持续提高个人及团队在生产能力、偏差处理、变更控制、环境监控、确认与验证、HSE等方面的能力；

Continuously improve the capability in production ability, deviation handled, environmental control, qualification and validation, HSE and so on.  

• 发展交叉岗位并参与多技能人才培养计划；

Develop cross job and multi skill talent cultivation.

工作交付Work Delivery 

• 根据要求确保个人培训及资质符合要求；

Ensure personal training and qualifications as required.

• 参与收获工序的生产操作，确保安全、合规、有效地进行生产操作，并按质按量交付产品；

Participate in the production operations of the harvesting process to ensure safe, compliant and efficient production operations, and deliver products with quality and quantity.

• 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；

Ensure that production activities are carried out in accordance with relevant process regulations, standard operating procedures and batch records.

• 按时填写和提交区域记录；

Completing and submitting district records on time;

• 确保生产活动中的数据完整性符合要求；

Ensuring compliance with requirements for data integrity in production activitie.

• 按时录入/提供相关生产数据 (MES、SAP、One LIMS、SMS2.0、CMS、SPC等)；参与解决生产中出现的问题；参与相关技术文件的编写；

Enter/provide relevant production data (MES, SAP, One LIMS,SMS2.0, CMS, SPC etc.) on time; participate in solving problems in production; participate in the preparation of relevant technical documents.

• 负责收获区域生产物料，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。

Responsible for collecting production materials and solution containers in the harvesting area, ensuring the supply of production materials, following up on non BOM material inventory, and applying for procurement in a timely manner.

• 参与本组所有验证方案/报告的编写和验证的执行。

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

• 参与计算机化系统的数据管理（数据备份，审计追踪 等）；

Participate in data management of computerized systems (data backup, audit trail, etc.).

• 负责收获区域健康、安全与环境（HSE）相关的个人防护装备（PPE）及其他安全物资的全面管理，数量、效期、完好性、合规性。

Responsible for the comprehensive management of personal protective equipment (PPE) and other safety materials related to Health, Safety, and Environment (HSE) in the harvesting area, including quantity, expiration dates, integrity, and compliance.

• 带领和培训新员工，保证新员工培训合格后上岗操作

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

质量系统实施Quality System Implementation 

• 协助生产主管调查生产领域中发生的偏差；根据实际情况提出处理变更行动，及时完成CAPA。

Assist the production supervisor to investigate the deviations in the production field; propose handling change actions according to the actual situation, and complete CAPA in 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。

Complete the required calibration/validation/verification activities of machines/equipment/plants on time with the assistance of related departments and continuous improvement group.

• 积极参与车间GMP自查，促进部门GMP合规性，参与车间持续改进；

Actively participate in workshop GMP self-examination, promote departmental GMP compliance, and participate in continuous improvement of workshops.

• 交付指定的持续改进项目或其他工作目标。

Deliver assigned continuous improvement projects or other work objectives.

实现目标、实施公司价值观和文化Achieving goals, implementing company values and culture 

• 提高个人工作积极性，协助生产主管完成域区工作，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。

Improve personal work enthusiasm, assist production supervisors to complete regional work, strengthen internal and cross-departmental communication and cohesion, so as to ensure the achievement of work goals and the highest work efficiency.

• 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。

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

• 认可公司文化，敢为人先(志存高远、心系患者、敢于创新、聚力同行)

Recognize the company culture,Take the Lead (Aim Higher, Act for Patients, Be Bold, and Lead Together).

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

• 学历，工作年限(对任职者要求):

Specific degree, duration of experience (Required to hold the job):

• 中专/高中或以上学历，1年以上相关工作经验。

Technical/High school or above, 1 years related working experience.

• 关键技术能力以及其他弹性技能:

Key technical competencies and soft skills:

• 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。会操作办公软件，如word、Excel、Powerpoint。

Know Pharmaceutical regulations, such as CGMP, Pharmacopoeia. Know documents drafting, processes, and guidance. Good at office software, such as Word, Excel, Powerpoint.

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。