CSV Specialist - Cell Therapy (AI-Enabled)

Katalyst CRO; Phoenix (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is looking for a skilled professional to lead Computer System Validation (CSV) activities focused on critical projects in the Cell Therapy area. The role ensures that validation deliverables are completed according to protocols while supporting leads in compliance efforts.

The candidate must have strong communication skills and experience with digital validation tools. A solid CSV background with a commitment to quality and compliance is essential.

Qualifications

• 8-10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• 5+ years of experience in Data Integrity/ALCOA+ principles.
• 5+ years of experience with CSA principles.
• 5+ years of experience with technical writing.
• Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11.

Responsibilities

• Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
• Maintain close communication with stakeholders regarding CSV needs and project status.
• Create documents that meet existing standards.
• Obtain and respond to reviews from stakeholders.
• Follow SOPs and industry best practices.

Skills

Excellent oral and written communication skills in English

Strong expertise in interviewing stakeholders

Advanced knowledge of MS Office suite and Visio

Experience with electronic document management systems

Familiarity with AI for document creation

Strong technical writing skills

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related

Tools

Qumas

SharePoint

Jira

ServiceNow

Job description

Katalyst CRO is looking for a skilled professional to lead Computer System Validation (CSV) activities focused on critical projects in the Cell Therapy area. The role ensures that validation deliverables are completed according to protocols while supporting leads in compliance efforts.

The candidate must have strong communication skills and experience with digital validation tools. A solid CSV background with a commitment to quality and compliance is essential.