Summer Intern, Sanford MSAT & Process Engineering

Duration: 2 Months

Location: 100% Remote

The Process Engineering Intern will be responsible for supporting process engineering and single-use technology efforts.  The incumbent will provide technical engineering support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment for GMP clinical manufacturing processes and be involved with the tech transfer of processes from small/lab scale to large/commercial scale.  The Process Engineering Intern will support operations and equipment in both upstream and downstream drug substance manufacturing.  The role includes collaboration with Manufacturing, Process Development, Quality, Facilities, Validation, and various vendors.

• Identify and implement process improvements for manufacturing and engineering workflow activities.
• Review Standard Operating Procedures and Batch Records.
• Create equipment Preventative Maintenance plans and critical spare parts lists for bioreactors, single-use mixers, chromatography skids, and tangential flow filtration skid.
• Perform Instrument Criticality Assessments.
• Update Single Use Component Flow Diagrams, Piping & Instrumentation Diagrams, and Process Flow Diagrams.
• Contribute to process descriptions, technical reports, batch data analysis, impact assessments/root cause investigations, and troubleshooting.
• Advance the Single-Use program development and execution.
• Support tech transfer and data management.

Gene therapy is touted as the medicine of the future and so this is a wonderful opportunity for the intern to learn about this cutting-edge science and how it will be manufactured.  It is also a rare opportunity to experience how a new facility attains GMP status; the intern will be exposed to activities and challenges that is unique to this situation, such as troubleshooting several unit operations simultaneously, developing automation recipes, creating Standard Operating Procedures (SOPs), determining equipment capabilities, and defining the process.  The Intern would gain invaluable experience that can be leveraged in future interviews, especially for open positions within

Intern Qualifications and Skills

• Pursuing a bachelor’s or master’s degree in life sciences  
• Must have an interest in pursuing a career in Life Sciences/Biotech/Pharmaceuticals
• Ability to manage workload effectively including planning, organizing, prioritizing, and meeting deadlines