Engineer II, Drug Product Development
About The Position
The Role: We are seeking a highly skilled and motivated Engineer II in Drug Product Development, to work in a team developing Moderna’s device combination products that enable clinical and future commercial supply. The primary role for this position will be to support drug product development activities including: device development, combination product development and packaging development. Applicants should have relevant device engineering related experience in the pharmaceutical space. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment. Here’s What You’ll Do: 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
- Education Qualifications - Masters or Bachelor’s Degree in on one of the following fields: Mechanical, Packaging or Chemical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above.
- Relevant Experience: 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 analysi
- This position is site-based, requiring you to be at Moderna’s site full-time.
- This position is not eligible for remote work.
Nice To Haves
- Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
- Preferred: Knowledge of GMP compliance.
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.
Benefits
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
