Process Engineer III

Job description

Department Description:

Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

·  Provide collocated technical leadership at manufacturing 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.

Position Overview/Key Responsibilities:

The Process Engineer III of Manufacturing Science and Technology (MSAT) is responsible for providing technical support to Sanofi Biologics cell culture operations as a member of Manufacturing Science Cell Culture team. The Process Engineer III MSAT:

·  Provide scientific/technical support, expertise, and guidance to commercial manufacturing at Sanofi/Partner/CMO sites including process monitoring, change assessment, and continuous improvement that result in safe, high quality products and continuously improving processes.
·  Provide technical leadership in process-related investigations. Anticipate, respond to, and permanently resolve issues that arise during production. Provide on-the-floor technical support if required.
·  Review production data and manufacturing processes. Lead process monitoring and continued process verification activities.
·  Generate conclusions based on data analysis and prepare presentations and reports to clearly communicate outcomes.
·  Partner with external and internal functions to identify, prioritize, transfer, implement, validate, and file product/process life cycle improvements.
·  Define relevant operational/technical standards and best practices for manufacturing sites.
·  Identify opportunities to debottleneck and maximize throughput and capacity utilization, and drive implementation of improvements.
·  Develop and act on individual development plan to remain current with technical and regulatory guidelines. Support documentation preparation to support regulatory activities.
·  Maintain and demonstrate knowledge of state-of-the-art principles and theories in area of responsibility.

This is a full time job with expectation to work during regular business hours with occasional on-call responsibility. The job may require occasional domestic or international travel.

Basic Qualifications:

·  Degree(s) in Engineering, Biological Sciences or equivalent.
·  BSc with 5+ industry years or Masters with 3+ industry years or PhD.
·  Understand key elements of unit operations in a manufacturing environment.
·  Understand core concepts in biotechnology or pharmaceutical industry
·  Proficient in MS Office and data analysis

Preferred Qualifications:

·  Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues
·  Strong verbal communication and technical writing skills. Experience communicating with business partners and senior management
·  Experience with cell culture or fermentation
·  Understand cGMP concept
·  Experience leading projects and/or cross functional teams
·  Proficient in process data analytics
·  Knowledge of Distributed Control System, Data Historian, LIMS, and MES

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.

#GD-SG

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.