Address
Form of work
SalaryResponsibilities:
- 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.
