Senior CSV Engineer - Validation & Compliance Lead

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a CSV Specialist to support the Computer Systems Validation lifecycle at its Durham, NC facility.

The role focuses on executing and documenting CSV activities, including plans, risk assessments, validation protocols, and traceability matrices to ensure compliance with 21 CFR Part 11 and related standards. The successful candidate will manage CSV tasks, communicate status to management and clients, and stay updated on regulatory changes affecting CSV programs.

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 aligning IT validation with other validation requirements.
• Biotech manufacturing knowledge from a cGMP facility.

Responsibilities

• Execute and document the CSV program at the Durham facility, including plans, risk assessments, test protocols and validation reports.
• Manage CSV team tasks to meet project deadlines and provide status updates to stakeholders.
• Plan and collaborate on CSV activities for lab and manufacturing systems.
• Stay current with regulatory trends and participate in audits as needed.

Skills

Lab equipment validation

IT validation

cGMP biotech knowledge

Project management

Communication

Attention to detail

Education

BS or MS in Engineering or IT

Job description

KBI Biopharma, Inc. is seeking a CSV Specialist to support the Computer Systems Validation lifecycle at its Durham, NC facility.

The role focuses on executing and documenting CSV activities, including plans, risk assessments, validation protocols, and traceability matrices to ensure compliance with 21 CFR Part 11 and related standards. The successful candidate will manage CSV tasks, communicate status to management and clients, and stay updated on regulatory changes affecting CSV programs.