We are looking for an experienced Senior Scientist I, Engineering – Design Verification Engineer to join our Combination Product Development & Drug Delivery Team to contribute to the development of exciting new drug / device combination products.
As a Senior Scientist I, Engineering – Design Verification Engineer you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. If you are a self-motivated & communicative person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity might be for you.
Responsibilities:
- Serve as Subject Matter Expert (SME) on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.
- Responsible for equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.
- Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing. Support investigations and issue resolutions. Present results to cross-functional teams.
- Utilize volumetric accuracy equipment and force testing machine. Familiarity with Zwick, viscometers, climate chambers, etc. is a plus.
- Support data analysis using statistics, experience with MiniTab is a plus.
- Develop, validate, and transfer test methods.
- Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.
- Experience with SolidWorks, Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred.
- Work in an independent manner under the guidance of a supervisor or technical lead.
- Comply with applicable policies and procedures, regulatory and safety requirements.
- Work on cross-functional teams including Quality, Regulatory Affairs, Clinical Team, and global partners