Senior CSV Specialist - Validation & Compliance

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior CSV Specialist to support the Computer Systems Validation lifecycle, author protocols, test scripts, and data analyses to ensure qualification for use. You will track regulatory changes and help prepare summary reports for audits.

The role requires 7+ years in CSV or related roles in pharma/biotech, strong technical writing, and the ability to lead validation efforts, coordinate with QA, and support Change Controls and CAPAs.

Qualifications

• Bachelor’s degree in Engineering or IT
• Seven (7) plus years of CSV experience in pharma/biotech
• Experience with 21 CFR Part 11 and GAMP guidance
• Strong technical writing and data analysis skills

Responsibilities

• Support CSV lifecycle for validation projects including protocol authoring
• Conduct data analysis and prepare summary reports for validation conclusions
• Coordinate validation efforts with QA, Change Controls, Deviations, CAPAs and audits

Skills

CSV lifecycle

Regulatory compliance

Technical writing

Data analysis

GAMP 21 CFR Part 11

Project coordination

Education

Bachelor’s degree in Engineering or IT

Master’s degree preferred

Tools

Microsoft Office (Excel)

Electronic document management systems

Job description

KBI Biopharma, Inc. is seeking a Senior CSV Specialist to support the Computer Systems Validation lifecycle, author protocols, test scripts, and data analyses to ensure qualification for use. You will track regulatory changes and help prepare summary reports for audits.

The role requires 7+ years in CSV or related roles in pharma/biotech, strong technical writing, and the ability to lead validation efforts, coordinate with QA, and support Change Controls and CAPAs.