MS&T Process Engineer – Cell Therapy, Onsite

Catalent Pharma Solutions; Princeton (NJ); On-site; USD 105,000 - 125,000; Full time

Benefits offered by this job

Career progression

Diversity & inclusion

Career growth opportunities

PTO + holidays

Tuition reimbursement

Job summary

Catalent is seeking a Process Engineer MS&T for our Princeton, NJ cGMP manufacturing facility. You will lead technology transfer, lifecycle management, and process optimization to deliver scalable, compliant cell therapy manufacturing.

In this role, you will partner with Manufacturing, Process Development, Engineering, and Supply Chain to drive new programs, validate processes, and improve quality, yield, and efficiency while upholding GDP and safety standards.

Qualifications

• Bachelor of Science in Science or Chemical/Biological Engineering.
• 5+ years of industry experience, incl 3 years in cGMP biologic or cell therapy.
• Strong understanding of bioprocessing principles.
• Knowledge of FDA cGMP regulations (21 CFR Parts 11, 210, 211).
• Experience with equipment qualification, process validation, and compliant operations.
• Excellent communication and collaboration across teams.

Responsibilities

• Serve as MS&T process expert, leading technology transfer and lifecycle management.
• Evaluate facility readiness through fit-gap analyses and feasibility reviews.
• Author and approve cGMP documentation including batch records and SOPs.
• Lead process validation activities and provide ongoing process monitoring.
• Troubleshoot manufacturing processes, manage deviations, and drive CAPAs.
• Analyze data to support process understanding and improvements.
• Identify and implement process optimizations to boost productivity and quality.
• Collaborate with Manufacturing, Process Development, and Engineering teams.
• Represent MS&T on cross-functional and client-facing projects.
• Support site performance goals and employee training initiatives.

Skills

Bioprocessing principles

cGMP regulations

Cross-functional collaboration

Communication skills

Project management

Statistical data analysis

Education

Bachelor of Science in Science or Chemical/Biological Engineering

Advanced degree in Science or Chemical/Biological Engineering

Tools

Microsoft Office

Data Historian

Distributed Control Systems

Autoclaves

Job description

Catalent is seeking a Process Engineer MS&T for our Princeton, NJ cGMP manufacturing facility. You will lead technology transfer, lifecycle management, and process optimization to deliver scalable, compliant cell therapy manufacturing.

In this role, you will partner with Manufacturing, Process Development, Engineering, and Supply Chain to drive new programs, validate processes, and improve quality, yield, and efficiency while upholding GDP and safety standards.