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Validation Engineering Specialist II

2 months ago


Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
About the Role

We are seeking a highly skilled Validation Engineering Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.

Key Responsibilities
  • Design and Implement Validation Strategies: Develop and execute validation plans for process, packaging, and cleaning validation to ensure compliance with regulatory requirements and company standards.
  • Prepare and Review Validation Protocols and Reports: Create 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: Collaborate with manufacturing teams to ensure smooth execution of validation protocols and identify areas for improvement.
  • Perform Data Collection and Statistical Analysis: Collect and analyze data to support validation activities and prepare summary reports to communicate findings.
  • Lead Annual Monitoring Programs: Develop and implement annual monitoring programs for cleaning and manage site cleaning matrix to ensure compliance with regulatory requirements.
  • Monitor and Coordinate Swab Sampling Activities: Coordinate swab sampling activities for cleaning validation to ensure accurate and reliable results.
  • Perform Risk Assessments: Conduct risk assessments for equipment, cleaning procedures, and manufacturing processes to identify potential risks and develop mitigation strategies.
  • Prepare Risk Assessments, Protocols, and Reports: Prepare risk assessments, protocols, and reports for Continued Process Verification program to ensure compliance with regulatory requirements.
  • Conduct Technical Discussions: Engage in technical discussions with clients, project managers, and other stakeholders to drive validation activities and ensure alignment with company goals.
  • Maintain a Safe Working Environment: Identify and report potential hazards to ensure a safe working 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. Proficiency in Microsoft Office programs and data analysis software.
Working at Thermo Fisher Scientific

We are a leading provider of scientific instrumentation and software for a wide range of industries, including pharmaceuticals, biotechnology, and life sciences. Our team is dedicated to delivering innovative solutions that help our customers advance their research and development goals.