Test Validation Engineer

Oxford Global Resources; Ireland; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Smart working options

Job summary

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.

Responsibilities

• 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.

Skills

CSV/CSA experience

Independent protocol authoring

Test protocol execution

GxP testing

Risk-based testing

Automation/AI testing exposure

Job description

We are seeking a Validation Tester to support a global programme delivering Computer System Validation (CSV), Computer Software Assurance (CSA) and risk management activities across GxP-regulated systems within the Life Sciences sector.

Key Responsibilities

1. Requirements Analysis and Testability Assessment

• Review URS, FRS, Design Specifications and related documentation to assess completeness, consistency and testability.
• Identify gaps, ambiguities, missing acceptance criteria and traceability concerns prior to test execution.
• Collaborate with Business Analysts, System Owners and Project Teams to clarify functional requirements.

2. Protocol Authoring and Review

• Independently author and review validation test protocols aligned with CSA and risk-based validation principles.
• Develop both positive and negative test scenarios based on system risk, intended use and requirement criticality.
• Ensure adequate requirement coverage and traceability within test protocols.

3. Dry Run and Test Readiness Activities

• Conduct protocol dry runs in development or lower environments to verify protocol accuracy and completeness.
• Identify protocol improvements and requirement gaps before formal qualification testing.
• Support review activities and incorporate feedback from Validation Leads and project stakeholders.

4. Controlled Environment Testing

• Execute formal qualification testing in controlled QA environments following approved procedures and validation documentation.
• Independently assess test results and determine compliance against defined acceptance criteria.

Required Experience and Qualifications

• Minimum 3-5 years experience in Computer System Validation (CSV), Computer Software Assurance (CSA) or regulated software testing within a GxP environment.
• Demonstrated experience independently authoring, reviewing and executing validation test protocols.
• Experience performing protocol dry runs, identifying requirement gaps and refining test coverage.
• Experience reviewing Functional Requirements Specifications (FRS), User Requirements Specifications (URS) and Design Specifications.
• Ability to independently assess functionality against requirements and document testing outcomes with minimal supervision.
• Experience managing deviations, incidents, defects and retesting activities through to closure.
• Familiarity with Computer Software Assurance (CSA) and risk-based assurance principles.
• Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and relevant data integrity guidance.
• Experience testing enterprise systems such as MES, ERP, LIMS, QMS or other regulated business applications.
• Exposure to automation or AI-enabled tools used in testing and validation.