Technical Ownership & System Administration
• Provide ownership, administration, and technical leadership of OSI Pi Data Historian and related manufacturing information systems.
• Ensure systems are robust, reliable, and available to meet business demand.
• Maintain systems in compliance with Amgen policies, procedures, and regulatory expectations.
• Develop lifecycle plans for systems, ensuring alignment with IS and Operations strategies.
System Enhancements & Improvements
• Lead and support system improvements including specifications, engineering documents, and SOPs.
• Plan and execute Manufacturing Information Systems projects.
• Develop and maintain data collection, processing, visualization, and trending capabilities.
Troubleshooting & Incident Management
• Lead root cause analysis, incident investigations, and troubleshooting.
• Implement CAPA, change controls, non-conformance actions, and validation activities.
• Ensure systems have appropriate disaster recovery and contingency plans.
Cross-Functional Collaboration & Leadership
• Collaborate with system users to encourage effective system use.
• Coach users on compliant use of systems.
• Work with Automation, Engineering, Operations, Quality, and IS teams.
Vendor & Project Management
• Develop support plans including vendor contracts.
• Lead business case development, planning, implementation, and documentation.
Innovation & Continuous Improvement
• Identify and implement innovative approaches to business challenges.
• Support or lead multi-site initiatives for global alignment.