MS&T Process Engineer for Cell Therapy

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

Benefits offered by this job

Medical, dental and vision benefits

Tuition reimbursement

Paid holidays and PTO

Job summary

Catalent’s Princeton, NJ site seeks a Process Engineer MS&T to provide technical leadership for cell therapy manufacturing. The role focuses on robust, scalable cGMP processes, technology transfer, and continuous improvement at a 100% onsite facility in Princeton, NJ.

The candidate will drive validation, documentation, and cross‑functional collaboration to deliver safe, high‑quality therapies. Competitive salary and benefits are offered.

Qualifications

• Bachelor’s degree in Science or Chemical/Biological Engineering.
• Minimum 5 years of industry experience including 3 years in cGMP biologic or cell therapy manufacturing.
• Strong knowledge of FDA cGMP regulations and their application to facilities, equipment, systems, and processes.

Responsibilities

• Lead technology transfer, lifecycle management, and manufacturing scale-up activities.
• Review and approve cGMP documentation including batch records, SOPs, validation docs, and reports.
• Lead process validation activities and support regulatory compliance and CAPA.
• Analyze manufacturing data to support process understanding and improvements.
• Collaborate with Manufacturing, Supply Chain, Process Development, and Engineering teams to enable equipment implementation and readiness.

Skills

cGMP Biologic Manufacturing

Process Validation

Technology Transfer

Data Analysis

Documentation

Regulatory Compliance

Education

Bachelor of Science in Science or Chemical/Biological Engineering

Tools

Data Historian

Distributed Control Systems

Autoclaves

G-REX

Job description

Catalent’s Princeton, NJ site seeks a Process Engineer MS&T to provide technical leadership for cell therapy manufacturing. The role focuses on robust, scalable cGMP processes, technology transfer, and continuous improvement at a 100% onsite facility in Princeton, NJ.

The candidate will drive validation, documentation, and cross‑functional collaboration to deliver safe, high‑quality therapies. Competitive salary and benefits are offered.