The Process Engineer is responsible for developing, implementing, and troubleshooting new methods used in manufacturing in support of the release of new products. This individual is responsible for the design and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. In addition, this individual may establish operating equipment specifications and improve manufacturing techniques, and is involved in new product scale-up, process improvement, and technology transfer activities.
- Draft SOPs, Batch Records, Specifications, and other documentation associated with process transfer to a Manufacturing environment
- Perform and document Risk Assessments
- Design, document and summarize Verification and Validation studies
- Write protocols, experimental summary reports, quality documents and other scientific literature associated with projects
- Work cooperatively in a timeline-focused, matrixed, team environment
- Present data to product/process development teams and management representatives
- Analyze large, complex data sets using spreadsheets and/or other data analysis packages