- Songling, China
Site Name: Suzhou Plant Tech Industry Park
Posted Date: Feb 25 2020
- The Process Engineer develops and sets the control strategy for assigned NPI's and leads the technical transfer of products from the pilot plant to the factory while working in conjunction with SC.
Key Responsibilities: 1. Strategy
- The Process Engineer develops and sets the control strategy for assigned NPIs and leads the technical transfer of the product from the pilot plant to the factory while working and in conjunction with SC.
- Robust, efficient, and validatable manufacturing processes for NPI and Stewardship projects.
- The Process Engineer contributes to the Development report and Technical Risk assessment and sets the Control Strategy for NPI's and relevant Stewardship projects.
- Manage and lead process development activities for assigned projects.
- Lead process engineering studies to identify new and improved processing techniques and technologies for introduction into R&D and Supply Chain.
- Write and/or review/authorize GMP-critical documentation, such as experimental reports, Batch Records, development and technology transfer reports.
- Engagement with R&D teams to understand technologies employed in Category and Regional products and associated challenges
- Lead the scale up/down from pilot plant to commercial scale, developing technical understanding and scale-up rules that can be used by other engineers (Quality by Design).
- Develop processing equipment understanding/characterization - at different scales to assist in development of scale-up models.
- Lead the manufacture and scale up of development batches and technology transfer of new products into commercial manufacturing facilities to the required cGMP standards.
- Develop an understanding of how key product quality attributes can be influenced by processing and can therefore be controlled (Process Understanding Control and Capability)
- Designs experiments and carries out scientific work with an awareness of state-of-the art technology. Creates investigation and research plans to fit overall project objectives.
- Plan and implement process development experiments at laboratory and / or pilot plant (1/10th) scale, using agreed engineering tools such as DOE and report the results
Knowledge/ Education / Previous Experience Required: 1. Educational Background
- Minimum Level of Education: Bachelor in Life sciences, preferably in Engineering
- Preferred Level of Education: Masters in Life sciences, preferably in Engineering
- 2 years' experience in the field of process development
- Good understanding of the Consumer Health / FMCG product development process
- Good understanding of CGMP requirements
- Successful track record of OTC / consumer product and process development.
- The incumbent must demonstrate good organizational ability and an ability to successfully operate in a highly matrixed and high pressure environment.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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