Senior Computer System Validation Engineer - GxP Compliance

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks a senior QA specialist to lead Computer System Validation for GxP systems, ensuring compliance with 21 CFR Part 11, SOX, EU Annex 11/22, and ISO quality standards.

You will author URS/FS, protocols, and reports, and support audit readiness while performing risk-based testing aligned with CSA fundamentals across Regulatory, Clinical, and IT stakeholders.

Qualifications

• 8+ years of experience in validation for GxP systems.
• Experience with 21 CFR Part 11, GxP, SOX, EU Annex 11/22.
• Strong documentation and audit readiness skills.

Responsibilities

• Ensure compliance with 21 CFR Part 11/820, GxP, SOX, and ISO standards.
• Author URS/FS, protocols, final reports, and validation plans.
• Maintain high-level understanding of Veeva Vault suits.
• Conduct risk-based testing aligned to CSA fundamentals.
• Support audit/inspection readiness and deviation/CAPA processes.

Skills

GxP validation

Audit readiness

Regulatory compliance

Education

Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy

Tools

Veeva Vault

Job description

Creative Solutions Services, LLC seeks a senior QA specialist to lead Computer System Validation for GxP systems, ensuring compliance with 21 CFR Part 11, SOX, EU Annex 11/22, and ISO quality standards.

You will author URS/FS, protocols, and reports, and support audit readiness while performing risk-based testing aligned with CSA fundamentals across Regulatory, Clinical, and IT stakeholders.