Process Engineer IV

Job title:

Process Engineer IV

Location:

Framingham, MA

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

• 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

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.

• 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

• Bachelor's degree in engineering or science discipline with 7 years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP) OR 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
• Experience with biologics upstream or downstream unit operations with perfusion or continuous operations a plus
• 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

Ability to gown and gain entry to manufacturing areas

• Shape the future of medicine and vaccine…