Summary
About the Role
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
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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
