CSV Engineer- Automation
Lebanon, Maine, United States of America
Contract
1 week ago
Key skills
CServiceNowCollaboration
About this role
- 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.