Engineer II, Drug Product Development

Moderna is a leading company in mRNA technology, focused on innovating how medicines are created and delivered. They are seeking an Engineer II in Drug Product Development to support the development of device combination products for clinical and commercial supply, requiring strong collaboration and planning skills in a fast-paced environment.

Responsibilities:

• Plan, organize and execute experiments to support combination product / device development – prepare study protocols and summarize the development results with presentations and study reports
• Contribute to combination product technical documentation including design history file documents, design input requirements, test plans/protocol/reports, engineering assessments, and design outputs
• Perform required risk assessments, propose mitigation strategies, and document approaches through appropriate risk management systems
• Communicate and collaborate with various groups such as analytical development to execute experiments and compile data
• Maintain an up-to-date ELN with good documentation practices
• Closely collaborate with multiple groups to generate innovative solutions to challenging device problems

Requirements:

• Masters or Bachelor's Degree in Mechanical, Packaging or Chemical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above
• 0 – 2 years post Master's Degree or at least 2 years post Bachelor's Degree
• Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
• Knowledge of statistical design of experiments (DoE) and analysis
• This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work
• Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
• Knowledge of GMP compliance