Computer System Validation Engineer

Katalyst CRO; Wilmington (DE); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Wilmington, DE seeks a senior Computer Systems Validation (CSV) expert to ensure GxP compliance across regulated environments. The role focuses on 21 CFR Part 11/820, SOX, EU Annex 11/22, and GAMP 5, with responsibility for audit readiness, deviation/CAPA management, and SOP/policy adherence.

You will author URS/FS, protocols, final reports, and validation plans, and develop risk-based testing aligned with CSA fundamentals.

Formación

• Over 8+ years of overall experience with at least 5 years in computer system validation for GxP systems.
• Bachelor of Science or Bachelor of Technology or Bachelor’s in Pharmacy.

Responsabilidades

• GxP compliance across regulated environments including 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL.
• Author URS/FS, protocols, final reports, validation plan/report.
• High-level understanding of Veeva Vault suites.
• Risk-based testing aligned to CSA fundamentals.
• Overall knowledge of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP.

Conocimientos

GxP compliance

21 CFR Part 11

Audit readiness

SOX

GAMP 5

ITIL

ISO 9001

Educación

B.S. / B.Tech / B.Pharm

Herramientas

Veeva Vault

Descripción del empleo

• 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

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