Job Details

  • Title: Process Engineer
  • Code: RCI-03992
  • Location: Ridgefield New Jersey (NJ) 07657
  • Posted Date: 04/05/2021
  • Duration: 6 Months

  Job Description

  • Experience in equipment start-up, qualification and validation is preferred.
  • 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.
  • Help create specifications for materials and excipients.
  • 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.
  • Provide technical leadership as a subject matter expert in multiple areas of responsibility.
  • 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.
  • Provide input to industrialization strategies and rationale for critical process parameters.
  • Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
  • Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
  • Document and interpret study results with recommendations.
  • 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.
  • 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 fill/finish, aseptic manufacturing or packaging operations as well as project/engineering lifecycle.
  • 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.

Education:
  • Advanced degree in sciences with 10+ year
  • Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
  • large scale process equipment design, scale-up implementation & validation experience.


Years of Experience: 6 - 9 Years