Senior CSV Validation Specialist - Cell Therapy

Katalyst CRO; Bridgeport (CT); On-site; USD 140,000 - 180,000; Full time

Job summary

Katalyst CRO in Bridgeport, CT is seeking an experienced CSV professional to lead computer system validation activities for enterprise GxP systems within cell therapy projects.

You will support validation leads, ensure deliverables per CSV SOP, and collaborate with Business, IT, and Quality teams. Strong writing, regulatory knowledge, and familiarity with validation tools and AI acceleration are essential.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 8–10+ years in pharma/biotech or regulated manufacturing.
• 5+ years in Data Integrity/ALCOA+ and CSA principles.
• 5+ years in technical writing and compliance.
• GMP/GLP/GAMP5 familiarity and FDA/ICH/EU Annex 11 knowledge.

Responsibilities

• Support creation, review, and approval of all CSV deliverables for in-house solutions.
• Maintain close communication with stakeholders to align CSV needs and project status.
• Create documents to established standards and respond to reviews by Business, IT, and Quality.
• Follow SOPs and industry best practices; use AI to accelerate documentation and testing where appropriate.

Skills

CSV validation

Data integrity/ALCOA+

CSA principles

Technical writing

Regulatory compliance

Cross-functional collaboration

AI in validation

Documentation practices

Education

Bachelor's degree in Engineering/Pharma/Related

Tools

MS Office

Visio

Qumas

SharePoint

ALM

Jira

ServiceNow

Job description

Katalyst CRO in Bridgeport, CT is seeking an experienced CSV professional to lead computer system validation activities for enterprise GxP systems within cell therapy projects.

You will support validation leads, ensure deliverables per CSV SOP, and collaborate with Business, IT, and Quality teams. Strong writing, regulatory knowledge, and familiarity with validation tools and AI acceleration are essential.