[Remote] Engineer II, Drug Product Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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
• reputed company 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

Skills

• Masters or Bachelor's Degree in Mechanical, Packaging or Chemical Engineering, Pharmaceutical Sciences, or any reputed company 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 reputed company 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 reputed company's site full-time. This position is not eligible for remote work
• Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
• Knowledge of GMP compliance

Benefits

• Best-in-class reputed company coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with reputed company 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 reputed company days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance

Company Overview