Senior Process Engineer, Biologics Manufacturing

BioSpace; Framingham (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Sanofi in Framingham, MA seeks a Process Engineer IV to lead manufacturing science initiatives for biologics drug substance. You will partner with manufacturing, quality, and process development to ensure capable, compliant, and cost-effective processes across the product lifecycle.

The role emphasizes technical leadership, data analytics, and continual improvement, with opportunities to drive Scale-Up, PAT, and digital process data systems.

Qualifications

• Bachelor's degree in engineering or science with GMP experience, or a Master's with GMP experience.
• 7+ years relevant GMP manufacturing experience or 5+ years with Master's.
• Strong track record in process data analytics and regulatory understanding.

Responsibilities

• Provide technical leadership to manufacturing and quality teams.
• Analyze process data to assess performance and identify improvements.
• Lead cross-functional projects and collaborate with process development teams.
• Review processes and data for regulatory readiness and changes.
• Support lifecycle management with CMC guidance.
• Mentor and lead team members across functions.

Skills

Process Data Analytics

Process Validation

Compliance

Biologics Manufacturing

Scale-Up

Manufacturing Systems

Cross-Functional Collaboration

Problem-Solving

Leadership

CMC Guidance

Education

Bachelor's degree in engineering or science (GMP)

Tools

DeltaV

Process Data Historian

LIMS

MES

Job description

Sanofi in Framingham, MA seeks a Process Engineer IV to lead manufacturing science initiatives for biologics drug substance. You will partner with manufacturing, quality, and process development to ensure capable, compliant, and cost-effective processes across the product lifecycle.

The role emphasizes technical leadership, data analytics, and continual improvement, with opportunities to drive Scale-Up, PAT, and digital process data systems.