Support activities related to the optimization of existing products/processes and implementation of new product launches and process changes to support existing products. Supports the process of exploring and evaluating project feasibility with an emphasis on technology requirements, facility compatibility, and compliance issues. Focus on continuous improvement in terms of process, cost, quality and production of both existing and future product lines. Demonstrates, understands and implementation of Quality by Design in product and process development.
Essential Duties and Responsibilities:
- Designing studies under instruction, executing experiments and data analysis to support GMP investigations, manufacturing change controls and to reduce reoccurring deviations
- Facilitates technology transfer from process development to GMP for new product introductions, exploring modifications of existing processes, execute process development protocols
- Develops process documentation and training materials for new processes, materials, and equipment
- Conducts activities related to the development of new processes, evaluating process cost, quality, and capability alternatives, and performing process under limited supervision
- Functions as a technical role model and resource/consultant to others
- Support of development of new product/processes, continuous improvement, testing, new equipment, new technologies and manufacturing process development.
- Work on multiple concurrent engineering/ R&D projects while ensuring their success in meeting respective objectives and timelines.
- Support continuous improvement projects addressing: process efficiency, product costs and performance
- Support Manufacturing in production troubleshooting and identification of root cause by conducting investigations by providing technical expertise guidance
- Follow project plan, timeline and logistics to support new product/process launches or process changes for existing products
- Participate in supporting transfer of technology to Manufacturing for new products/processes from the development stage to validation with adequate transition plans to transfer knowledge
- Support developmental and transfer activities including: research of new concepts, R&D testing, upstream and downstream process, in-process controls, scale-up, component changes and validation
- Participate in the development and implementation of reliable methods/processes, working across functional groups to implement within the various manufacturing areas
- Develop process/equipment SOPs and associated documents
- Work collaboratively with Validation department to design, conduct, and develop reports for experiments to characterize and validate new or changed manufacturing processes or new equipment/technology
- Support optimization of current processes by improving efficiency, throughput, reduce cost or increasing yield
- Compile and maintain critical data supporting R&D, engineering and validation work