The Senior Process Expert can work with shopfloor technicians and provide direct front line support to production activities using technical understanding and knowledge of cGMPS, SOPs, and process steps. This individual is accountable to support Manufacturing activities, develop training materials for production operators, train production staff, support process issues, protocol generation, general documentation support, deviation investigations, CAPA ownership, change record ownership, and continuous improvement of the process. The Senior Process Expert role can work as a production shift lead to coordinate the on shift management and other routine shopfloor team management.

Major Activities

•Support a culture of safety, quality, diversity, and inclusion.

•Can work with shopfloor technicians and provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.

•Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.

•Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends.

•Identify, assess, and own technical changes through GMP change control processes.

•Investigate deviations and determine root causes and identify CAPA.

•Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.

•Ensure processes are inspection ready at all times.

•Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.

•Support validation protocol generation and execution.

•Support on going self-learning and ensuring training is up to date.

•Provide guidance and support to production team through training and knowledge sharing.

•This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.

•This position may require shift work including weekends and off hours support.

•Strong interpersonal, written, communication skills along with problem solving and follow-up skills.

•Well organized, flexible and work with minimal supervision.

•Can work as a production shift lead to coordinate the on shift management.

•Be able to work as a production shift lead to coordinate the on shift management and other routine shopfloor team management.

Education:

Bachelor’s degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry or other science related field

Language:

Proficiency in Chinese and advanced English in listening/speaking/reading/writing

Experience:

Minimum requirements:

3+ years of experience in a GMP, R&D, or related Biopharmaceutical environment

3+ years of experience in a process support role in manufacturing

Continuous Improvement Methodology

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

the same as above