Eng, Process - Component

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

5.0 Responsibility职责

To be responsible for supervising all process activities in production area to ensure the manufacturing goals and projects are met to maintain the compliance with GMP, EHS guidelines and any other regulations.  Continually optimize the current processes and update related documents, including the procedure of material handling, operation, equipment, inspection and so on.

负责监督生产相关的所有工艺活动，确保生产目标和项目在遵照现行版GMP、环境健康和安全或其它规则的前提下完成。不断优化现有生产工艺并更新相关文件，包括物料处理、操作、设备及在线检查等。

The senior process engineer needs to manage the process team, instruct and evaluate the subordinates, improve the team's working ability and efficiency.

高级工艺工程师需要管理工艺团队，指导和评估下属，提高团队工作能力和工作效率。

Specific Responsibilities具体工作职责Write/update the production processes and procedure according to the cGMP requirement and Vantive requirement.

根据现行版GMP要求及万益特流程建立或更新生产工艺及流程。

As the key player to complete all the validation activities according to cGMP requirement and Vantive quality system.

根据GMP要求及万益特质量体系完成相关验证。

Continuously optimize the operational and quality processes and equipment to achieve the company strategy target.

持续优化生产、质量流程及生产设备实现公司战略目标

Participate and present documents/process as the key player in production area if the audit or inspection, ensure to pass theinspections or audit, take the effective actions if any findings related to production area.

代表生产参加内外部质量审核，确保生产文件及工艺顺利通过内外部质量审核，并对审核过程中由任何发现项采取有效措施。

Handle the non-conformity and CR cases for the validation and daily operation.

处理验证及日常生产中的偏差及变更。

Train the future employees, e.g. operators, technicians and engineers

培训部门其他人员，如操作工、技术员及工程师。

Capable of operating the equipment and other operational procedure.

能正确操作生产设备及其他生产岗位。

Use the LEAN tools to improve the current process and operation, ensure that the production provides cost-effective and high quality product timely and efficiently.

应用精益工具改善现有流程和操作，保证生产能及时有效地提供高质量产品及有效成本控制。

Assist dept. manager to achieve the KPIs and VIP project.

协助部门经理完成各KPI及VIP项目。

Understand and implement Vantive, division and regulatory EHS requirements as applicable to process engineer, report incidents of noncompliance with EHS laws and requirements or failure to carry out EHS responsibilities, which endanger the environment or people.

理解并执行万益特公司EHS对该职位的相关政策，报告不符合EHS法律的事故或对环境和人员造成伤害的行为。

Requirements职位要求 At least a bachelor in Pharmacy or Engineering.
药学或工科背景, 学士学位以上。 More than 3 year of production experience in a manufacturing environment preferably in the pharmaceutical, medical or similar industry.
制造行业3年以上生产工作经验；医药, 制药及相关行业优先。 Familiar with the processes of pharmaceutical manufacturing and GMP management.
熟悉药品生产流程及GMP管理规范。 Good oral and written English level.
良好的英语水平。 High level of attention to detail.
关注细节。  Independent and honest.
能够独立工作，诚实。  Have good leadership and communication skills.
具备领导能力并很好的沟通能力。 Demonstrate a strong trouble shooting ability and a desire to learn new things.
具备很强的问题解决能力，并有学习新事物的愿望。 Excellent manufacturing skill, to use the LEAN tools to solve the practical problem during the daily operation.
精艺生产技能，能熟练应用各种精艺生产工具来解决日常生产中遇到的问题。

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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