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

To apply for this job email your details to info@clinlabstaffing.com