Biotechnology Validation Specialist

9 hours ago


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

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

The successful candidate will have a strong background in validation, process engineering, or quality within the pharmaceutical or biotechnology industry. A Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field is required, with a minimum of 3 years of experience in a relevant role.

Key Responsibilities
  1. Design and implement validation strategies for processes, packaging, and cleaning validation.
  2. Prepare and review validation protocols and reports for various studies, including process, packaging, and cleaning validation.
  3. Monitor and coordinate manufacturing execution, providing training on validation protocols as needed.
  4. Analyze data, perform statistical analysis, and prepare summary reports.
  5. Lead annual monitoring programs for cleaning and manage site cleaning matrices.
  6. Coordinate swab sampling activities for cleaning validation and perform risk assessments for equipment and procedures.
  7. Develop and maintain risk assessment protocols, reports, and Continued Process Verification programs.
  8. Collaborate with clients, project managers, and stakeholders to drive validation activities forward.
Requirements
  • Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field.
  • Minimum 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnology industry.
  • Strong written and oral communication skills, with attention to detail and accuracy.
  • Excellent interpersonal skills, with ability to work collaboratively and communicate effectively with diverse stakeholders.
  • Proficiency in Microsoft Office programs and Mini-Tab data analysis software.
  • Demonstrated computer proficiency and English language skills.
Benefits

As a Biotechnology Validation Specialist at Thermo Fisher Scientific, you will enjoy a competitive salary range of $80,000 - $110,000 per year, based on experience and location. Our comprehensive benefits package includes medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.



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