The Process Scientist/Engineer represents the Process Sciences department before the company’s customers, regulatory agencies, and management. This individual will participate in new client process and ensure project objectives are completed. He/she will also contribute to the technology transfer of one or multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities.
Responsibilities:
- Support process validation and technical transfer of client projects as applicable
- Summarize report data
- Interacts with supervisor and reports results and interpretation of data, project deliverables, and process readiness
- Assists in developing GMP documentation including, but not limited to, process validation protocols, engineering test plans, and engineering documents
- Consults with senior peers on non-complex process engineering projects to learn through experience.
- Demonstrate skill with moderate level of proficiency in administrative work
- Acquire understanding of GMPs, safety, SOP, discipline practices, and terminology
- Acquire understanding of production troubleshooting
- Familiar with relevant literature
Proficiencies:
- Biology, chemistry, or biochemistry knowledge
- Independent use and application of computer systems and software for data acquisition and analysis
- Acquire understanding of basic production and production troubleshooting
- Understanding of analytical or process experimental design
- General knowledge of Excel, Word, and PowerPoint
Requirements:
- BS degree or equivalent; or four to ten years of related experience; or equivalent combination of education and experience
- Independent use and application of computer systems and software to perform basic data analysis
- Basic math and software skills (Excel data plotting, proficient with MS Word for memos and updates)
- Acquire understanding of GMPs, safety, SOP, discipline practices, and terminology
- Able to acquire understanding of basic production and production troubleshooting