Process Engineer IV

Sanofi•Framingham, MA

3d•$100,500 - $145,167•Onsite

About The Position

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. 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 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 people’s lives.

Requirements

Bachelor's degree in engineering or science discipline with 7 years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP)
Master's degree in Engineering or Science discipline with 5 years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP)
Demonstrated expertise applying fundamental principles to real-world problem solving and providing practical solutions to difficult technical issues
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
Process Data Analytics
Process Validation & Compliance
Biologics Manufacturing Operations
Process Development & Scale-Up
Manufacturing Systems & Tools
Independent Decision-Making
Cross-Functional Collaboration
Technical Communication
Problem-Solving & Ownership
Mentoring & Leadership

Nice To Haves

Experience with biologics upstream or downstream unit operations with perfusion or continuous operations a plus

Responsibilities

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