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The Specialist Information Systems (Pi Data Historian) is responsible for owning, administering, and providing technical leadership for OSI Pi and related Manufacturing Information Systems in a GMP-regulated environment. The role focuses on integration with process equipment and automation systems, designing and implementing data collection strategies, and enabling robust visualization, trending, reporting, and analytics capabilities that support manufacturing operations.
Job Responsibility:
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
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
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
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
Develop support plans including vendor contracts
Lead business case development, planning, implementation, and documentation
Identify and implement innovative approaches to business challenges
Support or lead multi-site initiatives for global alignment
Requirements:
Bachelor’s degree in Engineering, Information Systems, Computer Science, or Life Sciences
8+ years of experience
Minimum of 5 years experience implementing and managing OSI Pi Data Historian systems
Experience integrating OSI Pi with process equipment and automation systems
Experience with RtReports, SQL, PLC/DCS/SCADA systems, instrumentation, commissioning, validation, and data analytics
Nice to have:
Understanding of GAMP software lifecycle and IS development methodologies
Knowledge of system architecture and enterprise systems
Experience with validation, testing, and change control
Understanding of business intelligence and reporting technologies
Strong customer relationship and communication skills
Excellent problem-solving and decision-making abilities
Ability to work independently and within matrix environments
Experience managing multiple priorities in fast-paced environments
Strong critical-thinking skills
Excellent communication and interpersonal skills
Ability to present effectively and collaborate across business functions