Sr/Principal Computer Systems Validation Specialist

KBI Biopharma; Jacksonville (FL); On-site; USD 133,000 - 183,700; Full time

Benefits offered by this job

Annual bonus structure

Medical coverage

Dental coverage

Vision coverage

Paid PTO

Sabbatical program

401(k) matching

Job summary

KBI Biopharma in Jacksonville, FL is looking for an individual to lead IT Validation & Compliance oversight within a CDMO setting. The role requires 15+ years of experience in cGMP environments and expertise in data integrity and computer systems validation. Responsibilities include providing direction for validation deliverables, managing change controls, and ensuring compliance with regulatory standards. Benefits include medical, dental, vision coverage, and paid PTO. An annual bonus structure is also part of the package.

Qualifications

• 15+ years of experience in a cGMP environment in computer systems validation.
• Expert knowledge of 21CFR Part 11 and EU Annex 11.

Responsibilities

• Provide oversight of enterprise software validation globally.
• Manage validation services and deliverables for software projects.
• Ensure compliance with regulatory requirements.

Skills

cGMP environment experience

Computer systems validation

Data integrity

Regulatory compliance

Education

BS/MS degree

Job description

Job Description

This individual will 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. The role is responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the technical oversight of change controls, CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, the individual offers strategic and technical expertise for all global software validation matters, ensuring compliance with cGMPs, legal, regulatory requirements, and KBI internal requirements.

Job 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.

This position will be based in Durham, NC and require a regular on‑site presence.

Minimum Requirements

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

Salary Range

Senior: $118,000 – $162,800
Principal: $133,000 – $183,700

Benefits

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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants are strongly encouraged to apply.