AI-Enabled Cell Therapy CSV Validation Specialist

Katalyst CRO; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in the United States is seeking a seasoned CSV professional to lead validation activities for enterprise GxP systems in Cell Therapy projects. You will support validation leads to ensure deliverables and testing align with the Client CSV SOP and quality expectations.

Effective communication across Business, IT, and Quality is essential as you leverage digital validation tools and AI to accelerate document creation and testing.

Qualifications

• Bachelor's degree in a related scientific or technical field.
• 8–10+ years in pharma/biotech or regulated manufacturing.
• 5+ years Data Integrity/ALCOA+ and CSA principles.
• Strong GMP/GLP knowledge and FDA/ICH understanding.
• Excellent technical writing and documentation skills.

Responsibilities

• Support creation, review, and approval of CSV deliverables for in-house solutions.
• Maintain close communication with stakeholders on CSV needs and project status.
• Create documents to established standards.
• Respond to reviews from Business, IT, and Quality.
• Follow SOPs and industry best practices.
• Proficient in MS Office and Visio; understand technology platforms.

Skills

CSV validation

Regulatory compliance

Documentation

Cross-functional collaboration

Quality mindset

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology

Tools

Qumas

SharePoint

ALM

Jira

ServiceNow

EDMS

Visio

MS Office

Job description

Katalyst CRO in the United States is seeking a seasoned CSV professional to lead validation activities for enterprise GxP systems in Cell Therapy projects. You will support validation leads to ensure deliverables and testing align with the Client CSV SOP and quality expectations.

Effective communication across Business, IT, and Quality is essential as you leverage digital validation tools and AI to accelerate document creation and testing.