Cell Therapy CSV Validation Specialist

Katalyst CRO; Minneapolis (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Katalyst CRO in Minneapolis is seeking a role focused on Computer System Validation (CSV) for enterprise GxP systems. The candidate will support validation leads to ensure deliverables and testing are completed per required standards.

Key qualifications include a Bachelor's degree in a scientific discipline, 8-10+ years of experience in the field, and strong technical writing acumen. Familiarity with digital validation tools and excellent communication skills are essential for success in this role.

Qualifications

• 8-10+ years of experience in pharmaceutical, biotechnology, or regulated environments.
• 5+ years of experience in Data Integrity/ALCOA+ principles.
• 5+ years of experience with CSA principles.

Responsibilities

• Support creation, review, and approval of all CSV deliverables.
• Maintain communication with stakeholders about CSV needs.
• Follow SOPs and industry best practices.

Skills

Experience with current digital validation tools

Expertise in Data Integrity/ALCOA+ principles

Technical writing

GMP and GLP knowledge

Excellent communication skills

Education

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

Tools

MS Office suite

Visio

Electronic document management systems (e.g., Qumas, SharePoint)

Application lifecycle management (e.g., ALM, Jira)

IT service management systems (e.g., ServiceNow)

Job description

Katalyst CRO in Minneapolis is seeking a role focused on Computer System Validation (CSV) for enterprise GxP systems. The candidate will support validation leads to ensure deliverables and testing are completed per required standards.

Key qualifications include a Bachelor's degree in a scientific discipline, 8-10+ years of experience in the field, and strong technical writing acumen. Familiarity with digital validation tools and excellent communication skills are essential for success in this role.