Engineer, Drug Product Project Development (JP13343)

Job Title: Engineer, Drug Product Project Development (JP13343). We are recruiting an Engineer for a consulting engagement with a leading global biotechnology company. The ideal candidate should have a bachelor's degree in any engineering discipline or fresh master's degree with strong soft skills. Experience with software tools like SAP or Smartsheet's is required, though these can be learned on the job. The candidate will support senior staff in developing and characterizing drug product technologies and manufacturing capabilities, and assist in process validation and technology transfer projects.

Requirements

• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
• Assist in the design and execution of experiments in order to characterize and enable the implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
• Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
• Support development and maintenance of technology transfer tools (clinical and commercial)
• Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
• Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
• Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
• Development of digital tools and models by leveraging data analytics and programming skills
• Support at scale characterization and/or process validation runs as person in plant

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off