Computer Systems Validation (CSV) Engineer – Automation Systems

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We are looking for:

Computer Systems Validation (CSV) Engineer – Automation Systems

Location: Lebanon, Indiana (On-site)

Industry: Pharmaceutical / GMP Manufacturing

Role Summary

• We are seeking a high-caliber CSV Engineer to lead the validation lifecycle for critical automation and control systems. You will ensure that platforms like DeltaV, Rockwell, and PI Historian remain in a validated state while managing the validation scope for ServiceNow integrations.

Core Responsibilities

• Validation Lifecycle Management: Lead end-to-end V-Model activities, including the development of VP, URS, FS, DS, and CS.
• Protocol Execution: Author and execute IQ/OQ/PQ protocols and finalize Validation Summary Reports (VSR).
• Compliance & Risk: Conduct GAMP 5 risk assessments and 21 CFR Part 11 gap assessments for electronic records and audit trails.
• System Integration: Define and execute the CSV scope for ServiceNow, including CMDB connectors, API interfaces, and access workflows.
• Change Control: Manage validation impact assessments for system patches, upgrades, and revalidation requirements.
• Audit Readiness: Ensure all documentation aligns with FDA, EMA, and corporate quality standards for inspection readiness.

Technical Requirements

• Experience: Proven track record in CSV for automation/control systems within a GMP-regulated environment.
• Frameworks: Mastery of GAMP 5 methodology, V-Model lifecycle, and risk-based validation.
• Regulatory Knowledge: Deep understanding of 21 CFR Part 11 and Data Integrity (ALCOA ) principles.
• Systems: Proficiency with DCS, PLC/HMI, and Historian systems (e.g., DeltaV, Rockwell, PI Historian).

Preferred Qualifications

• Hands-on experience with ServiceNow platform validation in a GxP context.
• Familiarity with digital validation tools like Kneat or ValGenesis.
• Experience with Metasys or FactoryTalk platforms.

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