CSV Test Engineer

Job Description

Are you interested in taking the next step in your career in Computer System Validation in the pharmaceutical industry? Are you ready to challenge yourself in a highly-regulated and fast-paced environment? Are you experienced in IT Validation for GxP and enterprise systems and ready to work fully remote? You could be the perfect candidate for this opportunity!

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 completion.
• 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.

Key Requirements

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.

Desirable Experience

• 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.

Benefits

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid holidays

Location:

UK | remote