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.

Thanks & Regards

Rakesh Vangala

Team Lead

Burgeon IT Services LLC.

Email Id: rakesh@burgeonits.com OR rakesh.v@burgeonits.net

Website: www.burgeonits.com, LinkedIn: linkedin.com/in/rakesh-vangala-ba1422177