Remote Senior Principal - Enterprise Software Validation

KBI Biopharma Inc.; Durham (NC); On-site; USD 118,000 - 162,800; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401K matching with 100% vesting in 60 days

Employee recognition programs

Job summary

KBI Biopharma Inc. is looking for a Sr/Principal Computer Systems Validation Specialist in Durham, NC. This individual will oversee enterprise software validation in a cGMP environment, providing expert guidance on validation lifecycle deliverables and ensuring compliance with regulatory standards. Candidates need substantial experience in Data Integrity and FDA regulations. The salary range is competitive, with additional benefits including annual bonuses and full medical coverage.

Qualifications

• 15+ years for Principal, 8+ years for Senior in computer systems validation.
• Demonstrated expert knowledge of current regulatory guidance on Data Integrity.

Responsibilities

• Provide oversight of enterprise software validation from a global perspective.
• Review and approve validation lifecycle deliverables for enterprise software.
• Manage validation services and ensure compliance with regulatory requirements.

Skills

cGMP environment experience

Data Integrity expertise

Knowledge of 21CFR Part 11

Experience in FDA regulated manufacturing

Education

BS/MS degree

Job description

KBI Biopharma Inc. is looking for a Sr/Principal Computer Systems Validation Specialist in Durham, NC. This individual will oversee enterprise software validation in a cGMP environment, providing expert guidance on validation lifecycle deliverables and ensuring compliance with regulatory standards. Candidates need substantial experience in Data Integrity and FDA regulations. The salary range is competitive, with additional benefits including annual bonuses and full medical coverage.