Senior CSV Specialist — Pharma Validation Leader

KBI Biopharma; Durham (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a seasoned CSV Specialist to support the Computer Systems Validation lifecycle within the Validation Department.

You will author protocols, test scripts, and data tables to facilitate validation studies and re-qualifications, ensuring systems meet intended use. You will execute implementation tasks, manage work prioritization, and support audits, maintaining compliant documentation and coordinating validation for Change Controls, Deviations, CAPAs, and

Qualifications

• Bachelor’s or higher in Engineering or IT; Master’s preferred.
• 7+ years as a CSV Specialist in pharma/biotech.
• Strong knowledge of GAMP and 21CFR Part 11; protocol/reporting experience.
• Excellent writing, communication, and team-training abilities.

Responsibilities

• Support CSV lifecycle across validation; author protocols and test scripts.
• Analyze data, prepare summary reports, and draw acceptance conclusions.
• Track regulatory changes and implement compliant processes (21 CFR Part 11).
• Maintain validation documentation archive and respond to audits/requests.
• Coordinate validation support for Change Controls, Deviations, CAPAs, and Audit Observations.

Skills

Technical Writing

Regulatory knowledge

Project Management

Quality documentation

Communication

Team leadership

Data analysis

Excel proficiency

Education

Bachelor’s degree in Engineering or Information Technology

Master’s Degree

Tools

Microsoft Office

Electronic document management systems

Job description

KBI Biopharma, Inc. in Durham, NC, seeks a seasoned CSV Specialist to support the Computer Systems Validation lifecycle within the Validation Department.

You will author protocols, test scripts, and data tables to facilitate validation studies and re-qualifications, ensuring systems meet intended use. You will execute implementation tasks, manage work prioritization, and support audits, maintaining compliant documentation and coordinating validation for Change Controls, Deviations, CAPAs, and