Sr​/Principle Computer Systems Validation Specialist

Job Overview

Provide thought‑leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Deliver strategic and technical expertise for all global software validation related matters, ensuring compliance with cGMPs, legal and regulatory requirements, and KBI internal requirements.

• Provide oversight of enterprise software validation from a global perspective.
• Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.
• Provide oversight and management to validation managed services for associated projects.
• Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.
• Provide support for data integrity global initiatives.
• Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software.

• Principal: BS/MS and 15+ years of experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.
• Senior: BS/MS and 8+ years of experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.
• Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment.
• Demonstrated expert knowledge of 21
  
  CFR Part 11, EU Annex 11, and current regulatory guidance on Data Integrity.

• Salary range: $118,000 - $162,800 (Senior); $133,000 - $183,700 (Principal).
• Annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.

Durham, NC – regular site presence required.

KBI Biopharma, Inc. is an Equal Opportunity/Affirmative Action employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.