Cell Therapy Process Engineer, MS&T Lead

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

Benefits offered by this job

Medical benefits

Tuition reimbursement

Paid time off

Holidays

Job summary

Catalent's Princeton, NJ site is a key part of the company's cell therapy network and supports manufacturing across the product lifecycle. The Process Engineer MS&T will lead tech transfer, qualification, and lifecycle activities to ensure robust, compliant cell therapy processes.

The role reports to the MS&T Manager and involves hands-on support, data analysis, and collaboration with Manufacturing, Process Development, Engineering, and Quality teams to enable reliable, scalable production and

Qualifications

• Bachelor of Science in Science or Chemical/Biological Engineering.
• Minimum 5 years in industry, with 3 years in cGMP biologic or cell therapy manufacturing.
• Strong knowledge of FDA cGMP regulations (21 CFR Parts 11, 210, 211).
• Experience with equipment qualification, process validation, and compliant operations.
• Excellent collaboration and communication across cross-functional teams.

Responsibilities

• Lead MS&T processes during technology transfer and lifecycle management.
• Assess readiness for new programs via fit-gap analyses and risk reviews.
• Author and approve cGMP documents, batch records, SOPs, and reports.
• Lead process validation and ongoing monitoring with CAPA and deviations.
• Analyze data to support process understanding and improvements.
• Collaborate with Manufacturing, Supply Chain, Process Development, and Engineering.

Skills

Bioprocessing

Regulatory knowledge

Communication skills

Data analysis

Problem solving

Education

B.S. in Chemical/Biological Engineering

Advanced degree

Tools

Data Historian

Distributed Control Systems

Autoclaves

Job description

Catalent's Princeton, NJ site is a key part of the company's cell therapy network and supports manufacturing across the product lifecycle. The Process Engineer MS&T will lead tech transfer, qualification, and lifecycle activities to ensure robust, compliant cell therapy processes.

The role reports to the MS&T Manager and involves hands-on support, data analysis, and collaboration with Manufacturing, Process Development, Engineering, and Quality teams to enable reliable, scalable production and