Validation Engineering Specialist II

3 weeks ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Title: Validation Engineering Specialist II

About the Role:

We are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.

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

How to Apply:

If you are a motivated and detail-oriented individual with a passion for validation engineering, please submit your application, including your resume and cover letter, to our website.

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