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Validation Engineering Specialist II

2 months ago


Mississauga, Ontario, Canada ThermoFisher Scientific Full time
Job Summary

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 and Implement Validation Strategies: Develop and implement validation strategies for process, packaging, and cleaning validation to ensure compliance with regulatory requirements and company standards.
  • Prepare and Review Validation Protocols and Reports: Prepare and review validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation, and other additional studies to ensure accuracy and completeness.
  • Monitor and Coordinate Manufacturing Execution: Monitor and coordinate manufacturing execution and provide training on validation protocols to ensure smooth and efficient production processes.
  • Perform Data Collection and Analysis: Collect and analyze data to prepare summary reports and provide insights to support decision-making.
  • Lead Annual Monitoring Programs: Lead annual monitoring programs for cleaning and manage site cleaning matrix to ensure compliance with regulatory requirements.
  • Coordinate Swab Sampling Activities: Coordinate swab sampling activities for cleaning validation to ensure accurate and reliable results.
  • Perform Risk Assessments: Perform risk assessments for equipment, cleaning procedures, and manufacturing processes to identify potential hazards and implement controls.
  • Prepare Risk Assessments and Reports: Prepare risk assessments, protocols, and reports for Continued Process Verification program to ensure compliance with regulatory requirements.
  • Conduct Technical Discussions: Conduct technical discussions with clients, project managers, and other stakeholders to drive validation activities and ensure alignment with company goals.
  • Maintain a Safe Working Environment: Maintain a safe working environment and report potential hazards to ensure a healthy and safe work environment.
Requirements
  • Education: Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field.
  • Experience: Minimum 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnology industry.
  • Skills and Abilities: Strong written and oral communication skills, detail-oriented, organized, and able to work in a fast-paced environment.