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Hiring manager is only interested in candidates with Phara/Biotech experience with processing engineering design, equipment design and system ownership.
The position requires experience with processing engineering design, equipment design and system ownership in Phara/Biotech industry.
This position of Industrial Operations Senior Process Engineer, in the Manufacturing Technology (Mtech) function of Industrial Operations, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Sanofi Pasteur industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtech s function also provides daily support, for manufacturing and QC, toward industrial performance excellence. Develops process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions in IO to deliver following:
Responsible for process design and continuous improvements
Support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs.
Document and interpret study results with recommendations
Provide technical leadership as an subject matter expert in multiple areas of responsibility
Develop and execution of training programs for appropriate audiences
Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
Provide leadership, including project team leadership, within area of expertise
The Job Responsibilities Include:
Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
Skills:MS Office 2010
Expertise in one or more upstream process unit operation design typically used in biotech / vaccine manufacturing (seed expansion, viral growth and egg processes, harvest / clarification) as well as project / engineering lifecycle;
Knowledge of computer software common to mission (AutoCAD, process simulation / scheduling, CFD) is preferred.
Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Experience in equipment start-up, qualification and validation is preferred.
Education:BS in Chemical or Biochemical Engineering (or similar) with a minimum of 7 years industrial experience. Advanced degree in sciences with 10+ year s large scale process equipment design, scale-up implementation & validation experience.
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