Cell Therapy CSV Specialist – AI-Accelerated Validation

Katalyst CRO; Little Rock (AR); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a senior CSV specialist to lead validation activities for enterprise GxP systems in a cell therapy program. You will support validation leads to ensure deliverables and testing align with the Client CSV SOP.

Effective communication across Business, IT, and Quality is essential. Experience with digital validation tools and AI acceleration is a plus in a fast-paced project environment.

Qualifications

• 8-10+ years in pharmaceutical/regulated environments.
• 5+ years with Data Integrity/ALCOA+ and CSA principles.
• Strong technical writing skills and GMP/GLP knowledge.
• Experience with CSV protocols, reports, and CAPAs.
• Familiar with FDA/ICH/EU Annex 11 requirements.
• Proficiency with EDMS, change control systems, and Jira/ALM.

Responsibilities

• Support creation, review, and approval of CSV deliverables for custom solutions.
• Maintain communication with stakeholders on CSV needs and project status.
• Create documents to established standards and respond to reviews.
• Follow SOPs and industry best practices for validation activities.
• Assist with regulatory inspections and audits as needed.
• Utilize AI to accelerate document creation and testing.
• Leverage MS Office and Visio for complex documentation.
• Collaborate across Business, IT, and Quality teams.

Skills

ALCOA+ data integrity

CSA principles

Technical writing

GxP validation

Regulatory knowledge

FDA/ICH/EU familiarity

Cross-functional collab

AI for validation

Validation planning

Risk assessments (FMEA)

GMP/GLP knowledge

Documentation systems

Education

Bachelor's degree in Engineering/Pharma

Tools

EDMS (Qumas/SharePoint)

ALM/Jira

ServiceNow

MS Office & Visio

Job description

Katalyst CRO is seeking a senior CSV specialist to lead validation activities for enterprise GxP systems in a cell therapy program. You will support validation leads to ensure deliverables and testing align with the Client CSV SOP.

Effective communication across Business, IT, and Quality is essential. Experience with digital validation tools and AI acceleration is a plus in a fast-paced project environment.