cGMP MS&T Process Engineer – Cell Therapy (Onsite NJ)

The Fountain Group; Princeton (NJ); On-site; USD 69,000 - 83,000; Full time

Job summary

The Fountain Group is seeking an MS&T Process Engineer for a Princeton, NJ site. This role focuses on providing technical leadership in cGMP cell therapy manufacturing, driving seamless technology transfer, and ensuring robust processes from clinical to commercial stages.

The candidate will author and review critical GMP documents, support on-the-floor manufacturing, perform risk assessments, data trends, and lead process validation activities with the MS&T team.

Qualifications

• Bachelor's or advanced degree in science or engineering.
• Minimum 5 years of industry experience.
• Minimum 3 years in cGMP biologic/cell therapy manufacturing.
• Strong understanding of 21 CFR Part 11 and cGMP regulations.
• Experience with equipment qualification and validation strategies.

Responsibilities

• Provide technical leadership at Princeton, NJ cGMP manufacturing facility.
• Lead technology transfer and new product introductions.
• Perform risk assessments and gap analyses for new programs.
• Author and review internal cGMP documents (batch records, SOPs).
• Support manufacturing on the floor and drive CAPA and troubleshooting.
• Trend and analyze cGMP data to enable process improvements.
• Represent MS&T on project teams and assist with equipment onboarding.
• Support validation activities and lifecycle management.

Skills

Process engineering

Technology transfer

cGMP compliance

Cell therapy knowledge

Data analysis

Education

BSc or higher in science or engineering

Tools

Process validation

Statistical analysis

Documentation (SOPs, batch records)

Job description

The Fountain Group is seeking an MS&T Process Engineer for a Princeton, NJ site. This role focuses on providing technical leadership in cGMP cell therapy manufacturing, driving seamless technology transfer, and ensuring robust processes from clinical to commercial stages.

The candidate will author and review critical GMP documents, support on-the-floor manufacturing, perform risk assessments, data trends, and lead process validation activities with the MS&T team.