Validation Engineer - South San Francisco, United States - Katalyst HealthCares & Life Sciences

Description

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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