Senior Computer System Validation Engineer - GxP Compliance

Katalyst-Healthcares-; 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

Roles & Responsibilities :

• 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
• Authoring of URS/FS, protocols, final reports, validation plan/report
• High-level understanding of Veeva Vault suits
• Risk-based testing aligned to CSA fundamentals
• High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

Education & Experience :

• Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
• Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system