GMP Production Support Engineer

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. What You’ll Do

• 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

Do you have experience in eMaint?, * 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, * 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

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Important Candidate Safety Notice This position has been verified and officially approved by TCWGlobal. Please be aware that fraudulent recruiters and fake job postings may attempt to impersonate legitimate companies online. For your protection: * Only trust communication from verified TCWGlobal representatives

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