Sr./Principal Process Engineer (Combination Devices)

Our Vaccine client located in Woburn, MA is growing and looking to add a Sr/Principal Process Engineer to their combination device engineering team!  This will be a hands-on lab based role with opportunity for management.  Engineer will support their Drug-Device Combination Product Development and work cross-functionally, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs.  Responsibilities include but not limited to:

? Develop & implement new or improved processes and controls to increase quality and throughput for the company’s drug-device combination products.
? Conduct root cause analysis and develop timely solutions for production problems that might arise.
? Draft specifications for manufacturing equipment and work closely with outside equipment vendors
? Develop and execute process qualification and validation protocols, draft manufacturing SOPs and contribute to implementing and maintaining the Quality System.
? Train, supervise, and mentor other members of the process engineering and manufacturing team.
? Collaborate closely with cross-functional teams to support product development and manufacturing activities.

? BS, MS, or PhD in Chemical, Biomedical, or Mechanical Engineering, Materials Science, or a related discipline, with at least 5 years of direct process development experience in manufacturing of combination products, medical devices, or pharmaceuticals. Title will be adjusted commensurate with qualifications (Senior Engineer I, II, III or Principal).
? An understanding of phase-appropriate GxP requirements including batch records, raw material selection, process validation, and product specifications, and experience contributing to regulatory submissions
? Demonstrated expertise with statistical methods used to analyze manufacturing process performance.
? Experience working in clean room environments with bioburden controls.
? Excellent time and project management skills and proven ability to meet goals and deadlines.

*Must be able to commute and work onsite at the Woburn location.
**Must be eligible to work for any U.S. Employer for an indefinite amount of time.