CSV Validation Specialist - Cell Therapy Focus

Katalyst CRO; Little Rock (AR); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a professional focused on Computer System Validation (CSV) activities for critical projects in Cell Therapy. You will support validation leads and ensure compliance with Client CSV SOPs while working cross-functionally with IT and Quality teams.

The role requires a Bachelor's degree in a relevant field and 8-10 years of experience in regulated environments. Strong communication skills and a solid understanding of GMP, GLP, and FDA regulations are essential.

Qualifications

• 8-10+ years of experience in pharmaceutical or regulated environments.
• 5+ years with CSA principles.
• Working knowledge of FDA regulations and ICH guidelines.
• Ability to support regulatory inspections.
• Strong attention to detail and data integrity.

Responsibilities

• Support creation and review of CSV deliverables.
• Communicate with stakeholders on CSV needs.
• Create required documents following standards.
• Maintain compliance with SOPs and practices.
• Use AI for document creation and review.

Skills

Data Integrity/ALCOA+ principles

Technical writing

GMP, GLP, and GAMP 5 principles

Excellent communication skills

Experience with electronic document management systems

MS Office suite and Visio

Cross-functional collaboration

Regulatory compliance knowledge

Education

Bachelor's degree in Engineering or related fields

Tools

ALM

Jira

Qumas

SharePoint

ServiceNow

Job description

Katalyst CRO is seeking a professional focused on Computer System Validation (CSV) activities for critical projects in Cell Therapy. You will support validation leads and ensure compliance with Client CSV SOPs while working cross-functionally with IT and Quality teams.

The role requires a Bachelor's degree in a relevant field and 8-10 years of experience in regulated environments. Strong communication skills and a solid understanding of GMP, GLP, and FDA regulations are essential.