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.
- years of experience in validation engineering, preferably in the biopharmaceutical or biotechnology industry.
- Strong understanding of validation principles, methodologies, and regulatory requirements (, FDA CFR Part , Annex ).
- Experience with validation of bioprocess equipment (, 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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