Assistant Process Engineer # 26-26899

USTech Solutions • Devens, MA

3d

About The Position

The Assistant Process Engineer provides process validation support to the Devens Cell Therapy Facility (CTF). The role participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes. The posting describes the work under the title “Senior Specialist, MS&T Validation.”

The position is a six-month contract and reports to the Associate Director of Manufacturing Science and Technology Validation. US Tech Solutions is the staffing firm listed in the posting.

Requirements

• A minimum of 2 years of experience in biopharmaceutical operations, or equivalent.
• Experience with cGMPs and multinational biopharmaceutical/cell therapy regulations.
• Excellent verbal and written communication skills.
• Bachelor’s degree in science, engineering, biochemistry, or a related discipline.

Responsibilities

• Oversee CTF process validation activities, including Aseptic Process Simulations/Validations (Client/APV) and other lifecycle management changes.
• Prepare written protocols, reports, and summaries supporting validation studies.
• Ensure safe and compliant cGMP operations and maintain permanent inspection readiness.
• Participate in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.

What This Job Offers

• Career Level: Mid Level