M&S-Associate Engineer, Filling Support-Shenzhen

Job Information 职位信息

Job title职位名称: Associate Engineer, Filling Support 分装支持助理工程师

• Location工作地点：Shenzhen 深圳
• % Remote working and % of travel expected 远程办公和出差的概率：5%
• Job type工作类型: Permanent长期, Full time全职,
• Site/Unit 区域/事业部：Shenzhen/ M&S China, 深圳/中国制造与供应事业部

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：

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

• Carry out production activities strictly accordance with SOP and GMP requirements such as material cleaning, connection, packaging, sterilization, filter integrity testing, cleanroom cleaning,disinfection, environmental monitoring, preparation of disinfectants, and fill in relevant records.
• 严格按照SOP以及GMP要求进行物料清洗、连接、包装、灭菌、滤器检测、厂房清洁消毒、环境监测、配制消毒剂等生产活动并填写相关记录。
• Assist superiors in managing and overseeing regional production activities and promptly report any abnormal situations to the supervisor or manager.
• Training, assessment and management of temporary staff for influenza production.
• Participate in deviation investigation, CAPA implementation, Drafting and promotion and implementation of changes, self-inspection and other work. etc.
• CAPA执行、变更的起草推进及实施、自检等工作。
• Draft relevant documents (such as SOP, plan, report, etc.).
• (如SOP、方案、报告等)。
• Lead and perform DP support related validation (annual cleaning validation, refrigerator validation, sterilization autoclave loading validation and aseptic process simulation, etc.)
• DP支持相关验证(年度清洗验证、冰箱验证、灭菌柜装载验证和无菌工艺模拟等)
• Lead and advance the upgrade of the electronic batch record (PI) for the position and carry out related validation activities.
• PI）的升版，并执行相关验证活动。
• Obtain MES modeler qualification, be responsible for the annual updating of MES TO about DS support and DP support. Act as departmental modeler backup, assist the department in completing MES PI construction work in other process steps when necessary
• MES modler资质，负责原液支持和分装支持MES TO的年度更新升级，并作为部门modler backup，需要时协助部门其他工序完成MES PI搭建及年度升级工作
• Assist in completing GAP analysis work for pharmacopoeias, relevant regulations, sterile appendices, and global documents.
• Global文件等GAP分析工作。
• Participated in the company change and the deployment and implementation of DP SMS 2.0 PCU, and actively scheduled it during the production of PCU schedule; and performed shift work properly
• DP SMS 2.0 PCU的部署执行，作为PCU DCM排班计划员生产期间需积极排班；并做好代班工作
• Complete the work assigned by the superiors.

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。

• Experience: More than three years of experience in pharmaceutical or biological product technology operations.

工作经验: 三年以上制药或生物制品技术操作经验。

• Soft skill: Good communication skills. Good computer knowledge.

通用技能: 良好沟通技能, 较好的计算机知识。

• Technical skill: Good GMP awareness

专业技能: 良好的GMP意识

• Education: College degree or above in pharmaceutical or related majors.

教育背景: 制药或相关专业大专或以上学历。

• Languages: Good English level and can gradually improve at work.

语言要求: 较好的英语水平并能在工作中逐步提升。

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致

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。