Senior CSV Specialist – Validation & Compliance

KBI Biopharma; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a CSV professional to support the entire CSV lifecycle at the Durham facility.

You will execute and document CSV activities, generate plans, risk assessments, validation protocols, and ensure compliance with regulatory requirements including 21 CFR Part 11, EU Annex 11 and data integrity. The role requires 5-7 years in the field, lab equipment validation experience, IT validation alignment, and strong project management and communication skills.

Qualifications

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

Responsibilities

• Complete the execution and documentation of the CSV Program at the Durham facility. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
• Ensure project deadlines and performance standards for the CSV team are met while communicating status accordingly; Respond to inquiries from management, end users and clients, and provide status updates on a frequent basis.
• Plan, contribute and collaborate on CSV activities for lab and manufacturing systems.
• Keep current of trends, new products and technologies, and regulatory requirements that may have an impact on CSV. Participate in regulatory and client audits as needed.

Skills

Project management

cGMP knowledge

IT validation

Lab equipment validation

Regulatory compliance

Written and oral communication

Education

BS or MS in Engineering or IT

Tools

PowerPoint

Spreadsheets

Word processing

Email

Job description

KBI Biopharma, Inc. in Durham, NC, seeks a CSV professional to support the entire CSV lifecycle at the Durham facility.

You will execute and document CSV activities, generate plans, risk assessments, validation protocols, and ensure compliance with regulatory requirements including 21 CFR Part 11, EU Annex 11 and data integrity. The role requires 5-7 years in the field, lab equipment validation experience, IT validation alignment, and strong project management and communication skills.