CSV Engineer Automation Systems

Position: CSV Engineer Automation Systems

Location: Lebanon, IN Onsite

Duration: Long Term Contract

Mandatory skills*

Demonstrated experience in computer systems validation (CSV) for automation and control systems in a pharmaceutical/GMP-regulated environment.

Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches.

Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements.

Proficiency in developing validation deliverables across SDLC Life cycle.

Experience with DCS, PLC/HMI, and/or historian systems in a manufacturing environment.

Strong understanding of FDA and EMA regulatory expectations for computerized system validation.

Job Description*

Lead validation lifecycle activities for automation and control systems at LMF, including DeltaV, PI Historian, Rockwell PLC/HMI, and Metasys platforms.

Develop and execute validation plans (VP), user requirement specifications (URS), functional specifications (FS), design specifications (DS), and configuration specifications (CS) for automation systems.

Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

Generate and maintain requirements traceability matrices (RTMs) linking requirements through design, testing, and acceptance.

Author validation summary reports (VSR) documenting validation outcomes, deviations, and acceptance rationale.

Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across all in-scope automation systems.

Conduct risk assessments (including GAMP 5 categorization and functional risk assessments) for automation and control system components.

Manage validation change control by assessing the impact of system changes, patches, and upgrades on the validated state and determining revalidation requirements.

Support periodic review activities to confirm that automation systems remain in a validated state and that validation documentation is current.

Define and execute the CSV/validation scope for the ServiceNow platform in collaboration with the ServiceNow Process Owner.

Validate system integrations between automation platforms and ServiceNow, including event connectors, CMDB connectors, API interfaces, and access provisioning workflows.

Draft and maintain standard operating procedures (SOPs) related to computer systems validation for automation systems.

Support audit readiness by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and Lilly corporate quality standards

Provide support for data integrity assessments across automation and historian systems.

Assist with commissioning and qualification (C&Q) activities for new automation equipment.

Support remediation of validation findings from internal audits or regulatory inspections.

Advise on validation strategy for future automation system upgrades and expansions.