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Process Engineer II (Engineering)
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Process Engineer II (Engineering) Location - Framingham, MA(1-2 days onsite) Manager has requested additional resumes. Seeking mechanical area vs. controls and automation. Details around equipment design Manager seeking candidate with previous Validation Specialist or Validation Engineering experience. This role is not similar to a Process Engineer. Must understand technical aspects of the role, mechanics and fluid mechanics, control systems experience. 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 participate in testing of equipment. Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieve 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. Experience in equipment start-up, qualification and validation is preferred. Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering. Years of Experience: 3 - 6 Years

RIT solutions Inc

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