Job Summary

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Basic Qualifications:

Doctorate Degree OR

Master's Degree and 3 years of Engineering experience

OR Bachelor's Degree and 5 years of Engineering experience

OR Associate's degree and 10 years of Engineering experience OR

High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:

• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering

• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment

• Experience with managing technical teams, including setting priorities and leveling resources

• Technical writing experience

• Spanish language skills preferred

• Experienced with SolidWorks (or other 3D-CAD software)

• Familiar with equipment and software IOQ

• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs

• Experience with change controls, deviations, CAPA

• Experience with combination products and device regulatory requirements

• Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems

• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing

• Experience with machine controls (PLC, HMI) and vision systems