CSV Consultant

ROLE OVERVIEW

The Mid-Level CSV Consultant independently manages the end-to-end validation of computerized systems in GxP environments for pharmaceutical, biotech, and life sciences clients. This role requires solid regulatory knowledge, hands-on experience with both manual and automated testing methodologies, and the ability to interface directly with client stakeholders including QA, IT, and business system owners. The consultant is expected to operate with minimal supervision and may mentor junior team members.

KEY RESPONSIBILITIES

• Lead the development and execution of validation deliverables across the full SDLC: VMP, URS, FS, DS, IQ, OQ, PQ, and Validation Summary Reports.Lead the development and execution of validation deliverables across the full SDLC: VMP, URS, FS, DS, IQ, OQ, PQ, and Validation Summary Reports.
• Conduct and independently complete risk assessments per GAMP 5 for computerized systems ranging from Category 3 (Infrastructure Software) to Category 5 (Custom Applications).Conduct and independently complete risk assessments per GAMP 5 for computerized systems ranging from Category 3 (Infrastructure Software) to Category 5 (Custom Applications).
• Design and execute manual and automated test strategies for validated systems including LIMS, MES, ERP (SAP/Oracle), EDMS (Veeva Vault, Documentum), CTMS, and clinical data management systems.Design and execute manual and automated test strategies for validated systems including LIMS, MES, ERP (SAP/Oracle), EDMS (Veeva Vault, Documentum), CTMS, and clinical data management systems.
• Develop and maintain automated test scripts using enterprise tools (Tosca, UFT, TestComplete, Selenium) to improve test coverage and reduce validation cycle time.Develop and maintain automated test scripts using enterprise tools (Tosca, UFT, TestComplete, Selenium) to improve test coverage and reduce validation cycle time.
• Perform 21 CFR Part 11 and EU Annex 11 compliance assessments; identify gaps and author remediation plans.Perform 21 CFR Part 11 and EU Annex 11 compliance assessments; identify gaps and author remediation plans.
• Manage requirements traceability matrices (RTM) and ensure complete bidirectional traceability from requirements through test evidence.Manage requirements traceability matrices (RTM) and ensure complete bidirectional traceability from requirements through test evidence.
• Serve as day-to-day client liaison for validation projects; attend project meetings, report status, and escalate issues appropriately.Serve as day-to-day client liaison for validation projects; attend project meetings, report status, and escalate issues appropriately.
• Author and review change control documentation for validated systems in post-production environments.Author and review change control documentation for validated systems in post-production environments.
• Support inspection readiness activities; prepare validation binders and QA documentation for FDA, EMA, or MHRA audit response.Support inspection readiness activities; prepare validation binders and QA documentation for FDA, EMA, or MHRA audit response.
• Mentor and review work products of junior consultants on project teams.Mentor and review work products of junior consultants on project teams.

MANUAL TESTING COMPETENCIES

• Independent design and execution of IQ, OQ, and PQ test scripts across complex, multi-system integrations.Independent design and execution of IQ, OQ, and PQ test scripts across complex, multi-system integrations.
• Experience with functional, regression, boundary, and negative test case design in regulated environments.Experience with functional, regression, boundary, and negative test case design in regulated environments.
• Hands-on testing of web-based, client-server, and cloud-based GxP applications.Hands-on testing of web-based, client-server, and cloud-based GxP applications.
• Strong understanding of data integrity (ALCOA+) and how it applies to electronic records, audit trails, and access control testing.Strong understanding of data integrity (ALCOA+) and how it applies to electronic records, audit trails, and access control testing.
• Proficiency in identifying and documenting deviations, managing retest cycles, and authoring impact assessments.Proficiency in identifying and documenting deviations, managing retest cycles, and authoring impact assessments.

TEST AUTOMATION COMPETENCIES

• Proven ability to develop, maintain, and execute automated test scripts using at least one enterprise automation platform (Tosca, UFT, Selenium WebDriver, TestComplete).Proven ability to develop, maintain, and execute automated test scripts using at least one enterprise automation platform (Tosca, UFT, Selenium WebDriver, TestComplete).
• Experience implementing data-driven or keyword-driven automation frameworks within a validated environment.Experience implementing data-driven or keyword-driven automation frameworks within a validated environment.
• Ability to integrate automated testing into validation workflows while meeting GxP documentation requirements for automated test evidence.Ability to integrate automated testing into validation workflows while meeting GxP documentation requirements for automated test evidence.
• Familiarity with test management platforms: ALM/Quality Center, Jira + Xray, TestRail, or equivalent.Familiarity with test management platforms: ALM/Quality Center, Jira + Xray, TestRail, or equivalent.
• Understanding of continuous testing approaches and how automation fits within Agile/hybrid SDLC models in regulated industries.Understanding of continuous testing approaches and how automation fits within Agile/hybrid SDLC models in regulated industries.
• Scripting proficiency in Python, Java, VBScript, or similar; ability to perform script review and troubleshooting.Scripting proficiency in Python, Java, VBScript, or similar; ability to perform script review and troubleshooting.

QUALIFICATIONS

• Bachelor's degree in Life Sciences, Engineering, Computer Science, Pharmacy, or a related discipline.Bachelor's degree in Life Sciences, Engineering, Computer Science, Pharmacy, or a related discipline.
• 3–6 years of hands-on CSV experience in pharma, biotech, CRO, or medical device environments.3–6 years of hands-on CSV experience in pharma, biotech, CRO, or medical device environments.
• In-depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q10, and FDA/EMA data integrity guidance.In-depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q10, and FDA/EMA data integrity guidance.
• Track record of independently authoring and executing GxP-compliant validation documentation.Track record of independently authoring and executing GxP-compliant validation documentation.
• Experience with validated systems spanning at least two of the following: LIMS, MES, ERP, EDMS, CTMS, or pharmacovigilance platforms.Experience with validated systems spanning at least two of the following: LIMS, MES, ERP, EDMS, CTMS, or pharmacovigilance platforms.
• Strong written communication skills; ability to produce clear, inspection-ready documentation.Strong written communication skills; ability to produce clear, inspection-ready documentation.

PREFERRED QUALIFICATIONS

• ISPE GAMP 5 certification or equivalent professional credential in CSV/quality systems.ISPE GAMP 5 certification or equivalent professional credential in CSV/quality systems.
• Experience with CSV in cloud/SaaS environments (Veeva Vault, Salesforce Life Sciences, Medidata Rave).Experience with CSV in cloud/SaaS environments (Veeva Vault, Salesforce Life Sciences, Medidata Rave).
• Exposure to IQ/OQ/PQ for laboratory instruments or manufacturing equipment.Exposure to IQ/OQ/PQ for laboratory instruments or manufacturing equipment.
• Familiarity with CSV implications of Saudi Vision 2030 / UAE healthcare regulations or GCC regional regulatory frameworks.Familiarity with CSV implications of Saudi Vision 2030 / UAE healthcare regulations or GCC regional regulatory frameworks.