Process Engineer IV – MS&T

Job Title:

Process Engineer IV – MS&T

Location:

Framingham, MAAbout the Job The Process Engineer IV is a senior-level technical expert within Manufacturing Science, serving as a partner to biologics manufacturing drug substance operations and custodian of manufacturing processes. This role ensures that manufacturing processes are capable, compliant, in control, cost effective, and continuously improved. The Process Engineer IV provides collocated technical leadership and collaborates across other functions to drive process excellence throughout the product lifecycle.

This role will focus on single use technology across drug substance manufacturing and will be responsible for design, troubleshooting, and continuous improvement of complex critical single-use assemblies.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Department Overview Technical Science partners with biologics manufacturing operations as the custodian of manufacturing processes. The department is responsible for:
• Providing collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
• Anticipating, responding to, and permanently resolving issues that arise during production
• Aiding in the design of new processes and facilities with expertise in scale-up, manufacturability, PAT, capacity analysis, and cost analysis
• Leading the creation and use of digital process data analytic systems
• Partnering with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process lifecycle improvements.

Main Responsibilities Provide technical leadership in area of responsibility; deliver technical/scientific support, expertise, and guidance to manufacturing and quality teams

Lead the design, troubleshooting, and continuous improvement of complex, critical single-use assemblies, such as single-use bioreactor bags, alternating tangential flow devices, nano filtration assemblies, etc., ensuring fit, function, and performance in GMP manufacturing processes.

Ensure a solid understanding of engineering principles and theories in the area of responsibility and apply them to solve a range of complex problems in creative and practical ways Apply advanced troubleshooting skills for complex manufacturing deviations

Lead complex technical project teams or cross-functional teams between groups and organizations; provide input and coordinate support from process development teams

Review manufacturing processes and/or development and production data to assess process performance and identify opportunities for improvement

Support documentation preparation for regulatory purposes and stay current on regulatory requirements that impact manufacturing processes; evaluate and implement changes as required

Provide CMC support and guidance for product lifecycle management

About You Basic Qualifications Bachelor's degree is required. Engineering, science or related disciplines are preferred. 5+ years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP).Hands-on experience with design, troubleshooting, or continuous…