Cell Therapy CSV Specialist - AI-Enabled Validation Expert

Katalyst CRO; Los Angeles (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO in Los Angeles seeks an experienced CSV professional to lead validation activities for enterprise GxP systems. You will support validation leads, ensure deliverables, and drive testing in a fast-paced project environment.

The role requires strong writing skills, regulatory knowledge (FDA/ICH), and ability to leverage AI tools to accelerate document creation and testing, with effective communication across business, IT, and quality teams.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 8–10+ years in pharma/biotech/reg.

Responsibilities

• Support CSV deliverables for custom in-house solutions.
• Maintain stakeholder communication on CSV needs and status.
• Create documents to established standards.
• Obtain and respond to reviews by stakeholders.
• Follow SOPs and industry best practices.
• Advanced knowledge of MS Office and Visio.
• Understand technology platforms as needed for projects.
• Experience with electronic document management and ALM/Jira/ITSM tools.
• Excellent English communication, both oral and written.
• Familiarity with AI as an accelerator for document creation and testing.

Skills

Effective communication

AI as accelerator

Technical writing

Cross-functional collaboration

Data integrity mindset

Regulatory awareness

Project discipline

Education

Bachelor's degree in Engineering/Pharmaceutical Sciences/C Chemistry/Biology

Tools

MS Office

Visio

EDMS (Qumas/SharePoint)

ALM/Jira/ITSM tools

Job description

Katalyst CRO in Los Angeles seeks an experienced CSV professional to lead validation activities for enterprise GxP systems. You will support validation leads, ensure deliverables, and drive testing in a fast-paced project environment.

The role requires strong writing skills, regulatory knowledge (FDA/ICH), and ability to leverage AI tools to accelerate document creation and testing, with effective communication across business, IT, and quality teams.