Senior Principal: Enterprise Software Validation Leader

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

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.