Engineer

Payrate : $ - $

Summary :

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments on the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist in establishing experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups.

Responsibilities :

• 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 implementation of new capabilities and process changes such as filing, 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

Preferred Qualifications :

Must Have Skill :