Winter Co-op Process Engineering

Role Summary

The Process Engineering Co-op will report directly to the Sr. Process Engineer and will be responsible for assisting with equipment and process qualification, new process development, and the ongoing enhancement of manufacturing processes. This position is on-site at our Watertown, MA site and will begin on Monday, January 5th and end on Friday, June 26th.

Responsibilities

• Author and execute equipment commission and qualification protocols (IQ/OQ/PQ) and reports.
• Identify and implement process improvements to support site‚Äôs continuous improvement initiatives aimed at enhancing product quality, improving site safety standards, boosting operational efficiency, and minimizing waste.
• Create or revise process documentation, including standard operating procedures, work instructions, and batch records.
• Analyze development data and recommend new process development and/or changes to existing manufacturing processes.
• Collect and summarize in-process manufacturing data to support trending and statistical process control.
• Support failure investigations, root cause analysis, and participate in corrective and preventative action efforts.
• Design, procure, and fabricate simple tooling and fixtures.
• Source manufacturing equipment, and commission new equipment supporting semi-automated and automated solutions.

Qualifications

• Prior internship or co-op experience in the pharmaceutical or medical device industry is a plus.
• Working knowledge of cGMP regulations and FDA guidance applicable to drug product manufacturing.
• Excellent communication skills, both written and oral.
• Proficiency in the MS Office suite and familiarity with statistical analysis tools.
• Experience in CAD platforms (SolidWorks/AutoCAD preferred).
• Strong foundational engineering and analytical skills.
• Detail-oriented and well organized; strong willingness to learn.
• Demonstrated ability to be a self-starter and work well on a team.

Education

• Must be a student in a Bachelor‚Äôs degree/Masters or PhD program at an accredited college/university.
• Undergraduate student with a minimum of Rising status.

Preferred Field(s) of Study

• Mechanical, Biomedical, Chemical Engineering