Process Engineer IV - MS&T

About the role

• Location: Framingham, MA

About 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 at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

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

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 improvement of complex critical single-use assemblies.

Preferred Qualifications

• Demonstrated expertise applying fundamental principles to real-world problem solving and providing practical solutions to difficult technical issues
• Experience with biologics upstream or downstream unit operations with perfusion or continuous operations a plus
• Expansive experience leading the design, troubleshooting, and continuous improvement of single use technologies.
• Experience with extractable and leachable
• Understanding of cGMP concepts and familiarity with quality and regulatory frameworks
• Proficiency in process data analytics
• Knowledge of computerized systems in biopharmaceutical manufacturing environments (e.g., DeltaV, Process Data Historian, LIMS, MES)
• Experience leading projects and/or cross-functional teams
• Works independently with minimal supervision and direction; performs work that consistently requires independent decision-making and the exercise of independent judgment and discretion
• Ability to navigate ambiguous circumstances to meet final objectives
• Strong communication and technical writing skills; experience communicating with business partners and senior management

Technical Skills

• Process Data Analytics
• Process Validation & Compliance
• Biologics Manufacturing Operations
• Process Development & Scale-Up
• Manufacturing Systems & Tools

Soft Skills

• Independent Decision-Making
• Cross-Functional Collaboration
• Technical Communication
• Problem-Solving & Ownership
• Mentoring & Leadership

Special Working Conditions

• Ability to gown and gain entry to manufacturing areas.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• #GD-SG
• #LI-GZ
• #VHD
• Pursue progress, discover extraordinary

Additional information

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 () or

Pay and benefits

The salary range for this position is: $100,500.00 - $167,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.