Senior CSV Specialist - Pharma Validation (AI)

Katalyst CRO; San Francisco (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Katalyst CRO in San Francisco seeks a Senior CSV professional to lead Computer System Validation activities for critical Cell Therapy projects. You will support validation leads and ensure deliverables and testing align with the Client CSV SOP, communicating across Business, IT, and Quality.

Applicants bring 8–10+ years in regulated environments, deep CSVA, and strong technical writing. Experience with EDMS/ALM/Jira and AI-enabled document review is a plus.

Qualifications

• Bachelor's degree in engineering, pharmaceutical sciences, chemistry, biology, or related field.
• 8–10+ years in pharmaceutical/biotech/manufacturing environments.
• 5+ years experience with Data Integrity/ALCOA+ principles.
• 5+ years experience with CSA principles.
• 5+ years experience with technical writing.
• Working knowledge of GMP, GLP, and GAMP 5 principles.
• Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11.
• Experience developing, executing, and reviewing validation protocols and reports.
• Risk assessments (FMEA, impact assessments) and CAPAs.
• Ability to support regulatory inspections and audits (FDA, EMA, internal, client).
• Strong technical writing skills and data integrity.
• Proficiency with EDMS, change control systems.

Responsibilities

• Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
• Maintain close communication with stakeholders and team members on CSV needs and project status.
• Create documents to existing document standards.
• Obtain and respond to review by Business, IT, and Quality stakeholders.
• Follow SOPs and industry best practices.
• Utilize MS Office suite and Visio effectively.
• Understand technology platforms as needed for projects.
• Experience with electronic document management systems (e.g., Qumas, SharePoint); ALM/Jira; ITSM systems (ServiceNow).
• Communicate clearly in English; interview and interpret team requirements.
• Leverage AI as an accelerator for document creation and testing.

Skills

Communication

Technical Writing

Cross-functional Collaboration

Attention to Detail

Analytical Thinking

Team Player

Education

Bachelor's degree in engineering or related discipline

Tools

Qumas

SharePoint

Jira

MS Office

Visio

ALM

Job description

Katalyst CRO in San Francisco seeks a Senior CSV professional to lead Computer System Validation activities for critical Cell Therapy projects. You will support validation leads and ensure deliverables and testing align with the Client CSV SOP, communicating across Business, IT, and Quality.

Applicants bring 8–10+ years in regulated environments, deep CSVA, and strong technical writing. Experience with EDMS/ALM/Jira and AI-enabled document review is a plus.