Sanofi Group Process Engineer II in Framingham, Massachusetts
This position is part of Drug Substance-Upstream of Global Manufacturing Science & Technology (MSAT) within Specialty Care Industrial Operations (SCIO). The MSAT function assures robustness and economics of cell-culture based biologics (MAbs, Enzymes, etc.) manufacturing process life cycle management (LCM) by
Provide technical leadership to commercial manufacturing at Sanofi & external sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement.
Anticipate, respond to, and permanently resolve issues that arise during production.
Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
Lead the creation and use of digital process data analytic systems.
Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
Drive 2nd generation LCM process development & support key strategic initiatives (such as Facility of Future).
Lead Tech transfer, scale-up development & adaptation, process control strategy, process validation, comparability for biologics products introduction at Sanofi and external Industrial sites.
Review manufacturing processes and/or development and production data. Support complex investigation of the upstream manufacturing process.
Perform process data monitoring, advanced data analytics, and on-the-floor investigation to anticipate, respond to, and permanently resolve issues that arise during production.
Design and conduct necessary experiments, interpret results, and draw conclusion.
Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
Train manufacturing staff on new or changed processes and the use of equipment.
Interact with colleagues from various functions, such as engineering, manufacturing, and quality departments.
May provide technical and best practice guidance to new staff or contractors.
May lead small technical project teams and implement project plans.
- Bachelor’s Degree in engineering or science with 3 years of experience.
- Master’s degree in engineering or science with 1 year of experience.
Experience in biotechnology or the pharmaceutical industry.
Experience in purification, cell culture, or analytical methods.
Familiarity with root cause analysis and/or risk assessment.
Experience in cell culture or fermentation.
Experience in upstream process development.
Proficient in Microsoft Word, Excel, and PowerPoint.
Experience working with statistical analysis software.
Experience with project management.
Experience communicating with cross functional teams.
Effective communication skills.
Strong technical writing skills.
Experience with high level data analysis.
Special Working Conditions:
Ability to lift weight.
Ability to gown and gain entry to manufacturing areas.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.