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Validation Engineering Specialist II

1 month ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Summary:

As a Validation Engineering Specialist II at Thermo Fisher Scientific, you will play a critical role in ensuring the quality and compliance of our products and processes. You will be responsible for designing and implementing validation strategies, protocols, and reports for process, packaging, and cleaning validation. Your expertise will be essential in maintaining a safe working environment and ensuring that all documents conform to Patheon Standard Operating Procedures (SOPs) and Good Manufacturing Practices.

Key Responsibilities:
  • Design validation strategies for process, packaging, or cleaning validation
  • Prepare validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation, and other additional studies
  • Monitor and coordinate manufacturing execution and provide trainings on validation protocols
  • Perform data collection, statistical analysis, and prepare summary reports
  • Lead annual monitoring programs for cleaning and manage site cleaning matrix
  • Monitor and coordinate swab sampling activities for cleaning validation
  • Perform risk assessments for equipment, cleaning procedures, and manufacturing processes
  • Prepare risk assessment, protocols, and reports for Continued Process Verification program
  • Conduct technical discussions with clients, project managers, and other stakeholders to drive validation activities
  • Maintain a safe working environment and report potential hazards

Requirements:
  • Bachelor's/Master's in chemistry, Pharmacy, Engineering, Biotechnology, or related field
  • Minimum 3-year experience in validation, process engineering, or quality within the pharmaceutical/biotechnology industry
  • 1 year experience conducting statistical analysis is an asset

What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment