GMP Production Support Engineer

TCWGlobal•Bridgewater, NJ

5d•Onsite

About The Position

We are seeking Factory Service Engineers to support fully automated gene and cell therapy manufacturing platforms. These systems are actively running patient products in a GMP cell therapy manufacturing environment. This role is focused on keeping the process running, identifying issues quickly, performing basic equipment troubleshooting, and clearly communicating what is happening on the production floor. The ideal candidate has GMP manufacturing, process support, MSAT, biotech/pharma production, or equipment support experience, plus enough hands-on mechanical ability to troubleshoot basic equipment issues.

Requirements

Bachelor’s degree in engineering, life sciences, or related field, or equivalent technical experience
3+ years of experience in GMP manufacturing, biotech, pharma, cell therapy, or regulated production support
Strong process understanding; able to recognize when a process is not running as expected
Basic hands-on mechanical aptitude and troubleshooting ability
Ability to clearly explain what you are seeing so engineers or technical teams can resolve the issue
Experience supporting automated manufacturing equipment, process equipment, or production systems
Strong documentation skills and understanding of GMP expectations
Comfortable working in a fast-paced manufacturing environment where patient product is involved
Able to lift up to 50 lbs and work onsite in Bridgewater, NJ

Nice To Haves

Cell therapy, gene therapy, or biologics manufacturing experience
Experience with automated GMP manufacturing equipment
Experience with CMMS systems such as Blue Mountain, Maximo, SAP PM, or eMaint
Experience with deviations, CAPAs, change controls, SOPs, and GMP documentation
Basic electrical or mechanical troubleshooting experience

Responsibilities

Support gene therapy systems that are already built and processing patient cartridges
Monitor equipment and process performance during production runs
Identify process or equipment issues and communicate observations clearly to technical teams
Perform basic hands-on troubleshooting, including loose cables, sensor adjustments, simple mechanical issues, and equipment alarms
Support preventive maintenance, repairs, calibration, and troubleshooting activities
Work with manufacturing, quality, engineering, and service teams to resolve production issues
Document maintenance, troubleshooting, and support activities in a GMP-compliant manner
Support change controls, CAPA investigations, SOPs, and work instructions as needed
Participate in training to learn gene and cell therapy manufacturing platforms and process flow
Support after-hours/on-call needs as required for GMP operations