Process Development Engineer
Nano Precision Medical, United States
Job Description
Nano Precision Medical develops and applies cutting-edge technologies to design and produce implants that dramatically improve the standard of care for chronic disease treatment. We are searching for smart, highly motivated, problem solvers who have a broad technical knowledge base and deep command of foundational scientific and engineering principles to join our team.
In this role, you will be responsible for developing processes from the benchtop to pilot and commercial scale for novel drug delivery implants. Development engineers are responsible for characterizing and implementing GMP production processes with the appropriate documented justifications. As part of a cross-functional project team, you will collaborate closely with personnel in Ramp;D, Manufacturing, QA, and Analytical groups. Development engineers will provide support to the production team for resolving technical issues and conducting quality investigations.
To be successful in this role, you must be adept at working independently and in collaboration under a start-up environment. You must possess an understanding of engineering, mechanical, and chemical principles. You must have experience with drug and device cGMPs and as well as familiarity with aseptic manufacturing. As part a small growing company, you must be highly effective and driven to meet objectives in an efficient and pragmatic manner, while maintaining patient safety and regulatory compliance.As a Development Engineer you will.- Create and implement novel processes for manufacture of medical devices and drug formulation.
- Define process steps and write standard procedures.
- Design and conduct experiments to characterize processes and set controls appropriate for GMP manufacture.
- Assess and mitigate risk associated with product manufacturing.
- Work with vendors to design and purchase production and test equipment.
- Maintain detailed and accurate documentation of experiments and results.
- Prepare technical protocols and reports.
- Perform equipment and process qualification activities to support GMP production.
- Perform and assist with quality investigations for process deviations and OOS results.
- Support design control activities and establishment of design history files.
- Support production activities and to resolve manufacturing and technical issues.
- Perform technical transfer of processes to internal and external manufacturing team.
Requirements
You should have.- A BS in Engineering (Mechanical, Materials, or Chemical Engineering) or a related scientific field or equivalent combination of training and experience.
- Minimum of 4 years of experience in biotech, pharmaceutical, or medical device industry.
- An understanding of cGMPs and working in a regulated environment.
- Excellent verbal and written communication skills.
- Experience with aseptic manufacturing, sterilization processes, and design control is preferred.
Benefits
- Work in a collaborative, learning environment with cutting edge technology, research and development
- Flexible scheduling and generous perks
- Medical, Dental, Vision coverage and 401k