Manufacturing Engineer I/II
Location
Woburn, MA
Level
Full-Time
Department
Biotechnology
Type
Salary
Job Description
Posted on:
2025-04-28
Responsibilities
- Perform cGMP manufacturing operations according to documented procedures and batch records.
- Operate automated manufacturing equipment and complete production and testing records following Good Documentation Practices (GDP).
- Handle and visually inspect products, including the use of a microscope.
- Conduct root cause analysis and develop timely solutions for production problems.
- Develop & implement new or improved processes and controls to increase quality and throughput.
- Design tools, fixtures, and machines for manufacturing Vaxess’s products.
- Draft manufacturing and maintenance SOPs and contribute to implementing and maintaining the Quality System.
Job Requirements
- BS in Mechanical Engineering, Biomedical Engineering, or a related discipline.
- Relevant direct experience in medical devices or pharmaceuticals, such as internship or work experience.
- Familiarity or experience working in a cleanroom and/or a biomedical laboratory environment.
- Ability to stand or sit for up to 8 hours and perform tasks on laboratory benchtops and within glovebox isolators.
- Excellent time and project management skills with a proven ability to meet goals and deadlines.
- Demonstrated abilities to learn new skills and creatively solve challenging technical problems.
- Entrepreneurial spirit and drive to positively impact global human health.
