Senior Biologics Process Engineer — Process Excellence

Sanofi; Framingham (MA); On-site; USD 101,000 - 145,000; Full time

Job summary

Sanofi is seeking a Process Engineer IV in Framingham, MA, to serve as a senior technical expert in Manufacturing Science. You will partner with biologics drug substance operations, ensuring processes are capable, in control, and continuously improved across the product lifecycle.

You will lead cross-functional teams, drive debottlenecking, implement data-driven process analytics, and support regulatory documentation while collaborating across functions to accelerate development and scale-up.

Qualifications

• Bachelor’s or Master’s degree with GMP manufacturing experience.
• Proven ability to lead technical projects and cross-functional teams.
• Strong communication and technical writing skills; ability to operate in a regulated environment.

Responsibilities

• Provide technical leadership for manufacturing processes and support to quality teams.
• Apply engineering principles to solve complex problems and drive improvements.
• Lead cross-functional teams for process development, scale-up, and transfer.
• Review and analyze manufacturing data to identify opportunities for improvement.
• Support regulatory documentation and lifecycle management for products.

Skills

Process engineering

Continuous improvement

Quality/regulatory awareness

Cross-functional collaboration

Education

Bachelor's degree in engineering

Master's degree in Engineering or Science

Tools

DeltaV

Process Data Historian

LIMS

MES

Job description

Sanofi is seeking a Process Engineer IV in Framingham, MA, to serve as a senior technical expert in Manufacturing Science. You will partner with biologics drug substance operations, ensuring processes are capable, in control, and continuously improved across the product lifecycle.

You will lead cross-functional teams, drive debottlenecking, implement data-driven process analytics, and support regulatory documentation while collaborating across functions to accelerate development and scale-up.