Process Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Framingham
Posted on: March 14, 2023

Job Description:

Responsibilities:

• 
  
• Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
  
• Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
  
• 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 a subject matter expert in multiple areas of responsibility.
  
• Document and interpret study results with recommendations.
  
• 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, mas /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).
  
• 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.
  
  
  Requirements:
  
  
  • 
    
  • Experience in equipment start-up, qualification and validation is preferred.
    
  • Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
    
  • Advanced degree in sciences with 10+ years large scale process equipment design, scale-up implementation & validation experience.
    

Keywords: Katalyst Healthcares & Life Sciences, Framingham , Process Engineer, Engineering , Framingham, Massachusetts