Cell Therapy CSV Specialist - AI-Powered Validation

Katalyst CRO; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a senior CSV professional to lead and support Computer System Validation for enterprise GxP systems, focusing on cell therapy projects. The role emphasizes delivering compliant validation activities, collaborating with Business, IT, and Quality to ensure deliverables meet the Client CSV SOP.

You'll leverage advanced validation tools, explore AI-assisted document creation and testing, and apply ALCOA+ data integrity principles, GMP, GLP, and FDA/EU guidelines, while

Qualifications

• Bachelor’s degree in a relevant scientific or technical field.
• 8–10+ years in pharma/biotech, regulated environments.
• Experience with data integrity and ALCOA+ principles.

Responsibilities

• Support creation, review, and approval of CSV deliverables for in-house systems.
• Maintain close communication with stakeholders to track CSV needs and status.
• Follow SOPs and best practices; ensure compliant validation activities.
• Interacting with business, IT, and quality teams; document standards adherence.

Skills

CSV background

GxP validation

Excellent communication

Regulatory compliance

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline

Tools

Qumas

SharePoint

ALM

Jira

ServiceNow

Job description

Katalyst CRO is seeking a senior CSV professional to lead and support Computer System Validation for enterprise GxP systems, focusing on cell therapy projects. The role emphasizes delivering compliant validation activities, collaborating with Business, IT, and Quality to ensure deliverables meet the Client CSV SOP.

You'll leverage advanced validation tools, explore AI-assisted document creation and testing, and apply ALCOA+ data integrity principles, GMP, GLP, and FDA/EU guidelines, while