Sr/Principal Computer Systems Validation Specialist

KBI Biopharma, Inc.; North Carolina; On-site; USD 118,000 - 162,800; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401(k) matching with 100% vesting in 60 days

Employee recognition programs

Job summary

KBI Biopharma, Inc. is looking for a Principal or Senior Validation Specialist in Durham, NC. This role involves providing strategic oversight of global software validation to ensure compliance with cGMP and regulatory requirements. The ideal candidates will have extensive experience in computer systems validation and a thorough understanding of data integrity.

The position offers a competitive salary range and comprehensive benefits including medical coverage, a 401(k) matching program, and paid PTO.

Qualifications

• 15+ years of experience in a cGMP environment for Principal role.
• 8+ years of experience in a cGMP environment for Senior role.
• Expert knowledge of 21CFR Part 11 and EU Annex 11.

Responsibilities

• Oversee enterprise software validation globally.
• Provide validation direction for validation lifecycle deliverables.
• Review and approve enterprise software change controls.

Skills

cGMP experience

Data Integrity

Computer Systems Validation

Regulatory Compliance

Education

BS/MS in relevant field

Job description

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.

Responsibilities

• 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.

Qualifications

• 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 21CFR Part 11, EU Annex 11, and current regulatory guidance on Data Integrity.

Salary and Benefits

• 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.

Location

Durham, NC – regular site presence required.

EEO Statement

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.