Quality Validation Engineer-Process Equipment Design At North York, On

Position: Quality Validation Engineer-process equipment design

Location: North York, ON

Type of Employment: Fulltime-Contract

Duration: 12+month

Client: Pharma

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 input as a subject matter expert in multiple areas of responsibility.

Document and interpret study results with recommendations.

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 assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).

Expertise in one or more upstream and downstream process unit operation design typically used in biotech/vaccine manufacturing (seed expansion, viral growth and 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, 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.

Advanced degree in sciences with min of 3-6 years large scale process equipment design, scale-up implementation & validation experience.

Years of Experience: 3-6 years

Thanks,

Priyanka Singh, IT Staffing, Canada - The Judge Group

[email protected] | www.judge.com

www.linkedin.com/in/priyanka-singh-70675472/