CSV Lead: Biopharma Compliance & Validation Expert

KBI Biopharma; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma in Durham, NC seeks a seasoned CSV professional to support the full CSV lifecycle at the Durham facility. You will execute and document CSV activities, ensuring compliance with 21 CFR Part 11, EU Annex 11, and data integrity standards.

The role emphasizes collaboration with lab and manufacturing systems, risk assessments, validation reports, audits, and ongoing regulatory awareness to meet evolving requirements.

Qualifications

• BS or MS in Engineering or Information Technology.
• 5-7 years of industry experience.
• Lab equipment validation knowledge and experience required.
• Experience with IT computer validation and alignment of IT validation with other validation requirements required.
• Knowledge of biotech manufacturing from cGMP facility.
• Demonstrated project management ability with good written and oral communication skills required.

Responsibilities

• Complete the execution and documentation of the CSV program at the Durham facility, including plans, risk assessments, specifications, testing, change controls, traceability, and validation reviews.
• Ensure CSV team deadlines and performance standards are met; provide frequent status updates and respond to inquiries from management, end users, and clients.
• Plan and collaborate on CSV activities for lab and manufacturing systems.
• Stay current on regulatory trends, products, and technologies affecting CSV and participate in audits as needed.

Skills

Lab equipment validation

IT computer validation

cGMP familiarity

Project management

Technical communication

Education

BS or MS in Engineering or IT

Job description

KBI Biopharma in Durham, NC seeks a seasoned CSV professional to support the full CSV lifecycle at the Durham facility. You will execute and document CSV activities, ensuring compliance with 21 CFR Part 11, EU Annex 11, and data integrity standards.

The role emphasizes collaboration with lab and manufacturing systems, risk assessments, validation reports, audits, and ongoing regulatory awareness to meet evolving requirements.