Validation Engineer

3 weeks ago


South San Francisco, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Validation Strategy: Develop validation strategies aligned with regulatory standards.
  • Protocol Generation: Author and review validation protocols for processes and equipment.
  • Execution: Lead validation studies and analyze data, ensuring adherence to timelines.
  • Reporting: Prepare comprehensive validation reports with findings and recommendations.
  • Compliance Oversight: Ensure adherence to regulatory requirements and industry standards.
  • Continuous Improvement: Identify optimization opportunities and drive improvement initiatives.
  • 5+ years of experience in validation engineering, preferably in the biopharmaceutical or biotechnology industry.
  • Strong understanding of validation principles, methodologies, and regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 15).
  • Experience with validation of bioprocess equipment (e.g., bioreactors, filtration systems) and/or cell therapy manufacturing processes is highly desirable.
  • Proficiency in statistical analysis tools and techniques for validation data analysis.
  • Excellent communication skills, with the ability to effectively collaborate across multidisciplinary teams.
  • Detail-oriented mindset with a commitment to ensuring accuracy, compliance, and quality in validation activities.

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