CSV/CSA Validation Test Engineer – GxP Systems

Oxford Global Resources; Irlande; Sur place; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Smart working options

Résumé du poste

Oxford Global Resources seeks a Validation Tester to support a global programme delivering CSV, CSA and risk management across GxP-regulated systems in Life Sciences. Responsibilities include reviewing URS/FRS/Design Specs, independently authoring and reviewing validation test protocols, and performing dry runs to ensure readiness before formal qualification testing in controlled QA environments.

You will assess results against defined acceptance criteria and manage deviations as needed.

Qualifications

• 3–5 years experience in CSV/CSA or regulated software testing within a GxP environment.
• Experience authoring, reviewing and executing validation test protocols.
• Experience performing protocol dry runs and refining test coverage.
• Familiarity with URS/FRS/Design Specifications and risk-based validation.

Responsabilités

• Analyze requirements and assess testability, gaps, and traceability.
• Author and review validation protocols aligned with CSA and risk-based validation.
• Conduct protocol dry runs and incorporate feedback to ensure readiness.
• Execute formal testing in controlled QA environments and assess results.

Connaissances

CSV/CSA experience

Independent protocol authoring

Test protocol execution

GxP testing

Risk-based testing

Automation/AI testing exposure

Description du poste

Oxford Global Resources seeks a Validation Tester to support a global programme delivering CSV, CSA and risk management across GxP-regulated systems in Life Sciences. Responsibilities include reviewing URS/FRS/Design Specs, independently authoring and reviewing validation test protocols, and performing dry runs to ensure readiness before formal qualification testing in controlled QA environments.

You will assess results against defined acceptance criteria and manage deviations as needed.