Senior GxP Computer System Validation Engineer

Katalyst CRO; Wilmington (DE); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GxP compliance

21 CFR Part 11

Audit readiness

SOX

GAMP 5

ITIL

ISO 9001

Formazione

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

Strumenti

Veeva Vault

Descrizione del lavoro

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.