Process Engineer II

Process Engineer II

TorontoIntroduction

We are currently hiring a Process Engineer for our client based in Toronto. The Process Engineer will provide input to industrialization strategies and rationale for critical process parameters. The successful candidate will be a Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.

Responsibilities

• 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 input as a subject matter expert in multiple areas of responsibility
• 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.)
• Process control strategies
• Provide technical assistance to manufacturing and quality operations for process troubleshooting, health authority inspections to achieving site metrics (+QDCI)
• Use expertise in one or more upstream and downstream process unit operation

Requirements

• Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering
• Advanced degree in sciences with min of 3-6 years large scale process equipment design scale-up implementation and validation experience
• Expertise in one or more upstream and downstream process unit operation design typically used in biotech/vaccine manufacturing (seed expansion viral growth & egg processes harvest/clarification purification and sterile filtration) as well as project/engineering lifecycle
• Knowledge of computer software common to mission (process simulation/scheduling CFD) is preferred
• Proficient with structured methodologies such as Good Engineering Practices Quality by Design Space and 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 & root cause analysis communicate with internal & external team members
• Experience in equipment start-up qualification & validation is preferred

What We Offer

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