Computer System Validation Manager Jobs in Kentucky

Stefanini Group is looking for IT Support Analyst - II for a globally recognized company!
For interested applicants, click the apply button or you may reach out to Alfher Hidalgo at / for faster processing. Thank you! We're seeking an IT Operations Analyst Candidate with a strong technical foundation and extensive experience supporting complex manufacturing and laboratory IT environments. This role requires a seasoned professional who can independently lead system deployments, troubleshoot critical production issues, and act as a trusted technical partner to Operations, Quality, and Engineering teams.Job Responsibilities:Understand the business requirements; perform analysis and translation of business requirements to technical specifications; provide solutions design, build, and deploy IT solutions and services; provide maintenance and support.Act as IT service and solution facilitator for IT factory-based systems (Manufacturing, Quality, Warehouse Management, Open+, Logistic supply chain)Actively participate in the implementation of new systems and digital initiatives in the Manufacturing and Supply Chain areas.Collect business requirements for changes in processes and technical areas.Formalize scope and deliverables for technical processes and changes.Execute the deployment and localization of the global IT system solutions.Execute Digital Pillar activities (Align with Operations zero loss journey and boot performance by digital capabilities).Provide maintenance and support for local and global IT system solutions. Perform troubleshooting and solving issues as they occur in day-to-day business.Adhere to relevant policies, procedures, and standards to achieve quality and compliance of solutions and services.Collaborate with equipment vendors and internal stakeholders to qualify laboratory instruments and systems in accordance with GxP guidelines.Prepare, review, and maintain Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for IT systems.Track and document configuration changes to lab equipment and associated software to ensure traceability and compliance.Coordinate and execute IT resiliency and disaster recovery procedures specific to IT systems, ensuring business continuity and data integrity.Support periodic validation and requalification of Lab IT systems to maintain compliance with GxP and regulatory standards.Act as primary IT liaison for lab-based systems, ensuring integration with global IT platforms while meeting local compliance and operational needs.Monitor and respond to lab IT incidents, ensuring timely resolution and proper escalation where required.
Skills, Licenses, Knowledge, Education and Training Requirements:Bachelor's degree in computer science, Information Systems, Engineering, or a related technical field (or equivalent experience)7+ years of progressive experience in IT operations, application support, or solution delivery within manufacturing or regulated industrial environmentsExperience working in multinational/global organizations supporting site-level deployment of global systemsStrong background in GMP, GAMP, and Computer System Validation (CSV)Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environmentsStrong SAP experience (ECC and/or S/4HANA) supporting manufacturing, supply chain, or quality processesDeep understanding of manufacturing execution, materials management, and supply chain workflowsProvide operational support for mission-critical production and lab systems.Support incident triage, root cause analysis, and corrective actions to minimize production impactExecute validation activities in accordance with established CSV and GxP frameworksImplement approved system changes following established change management and validation proceduresSupport system upgrades, patches, and enhancements in coordination with global IT teamsLevel of Knowledge, Skills, and Authority:Advanced troubleshooting across applications, database, and interface layersStrong SQL skills for data analysis, incident investigation, and validation supportExperience with system integrations, data flows, and change control in validated environmentsExperience with IT resiliency, disaster recovery, and business continuity for mission-critical systemsWrite and execute SQL statements to support operational reporting, incident investigation, data validation, and root cause analysis; troubleshoot SQL query performance, data integrity, and interface-related data issues.Provide hands-on support for Operational Technology (OT) systems in manufacturing and laboratory environments, including MES/LES, equipment interfaces, historian systems, and shop floor applications.Understand IT/OT system platform architecture, including application, database, interface, middleware, and infrastructure layers, and how they interact within regulated manufacturing environments.Troubleshoot issues across the IT/OT boundary, identifying root causes related to applications, databases, interfaces, or network connectivity, and supporting OT teams during production-impacting events.Support OT and manufacturing teams with real-time troubleshooting of system behavior, data flow disruptions, and integration issues affecting production and quality processes.Demonstrate working knowledge of network and connectivity concepts, including firewall rules, ports and protocols, and network segmentation between IT and OT zones.Collaborate with network and infrastructure teams to diagnose and resolve connectivity issues impacting manufacturing, laboratory, and OT systems while adhering to site security and compliance standards.
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