Specialist Business Analyst (Pi Data Historian)

r 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.

ROLES & RESPONSIBILITIES

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.

BASIC QUALIFICATIONS & EXPERIENCE

• Bachelor's degree in Engineering, Information Systems, Computer Science, or Life Sciences.

• 8+ years of experience with a 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.

PREFERRED EXPERIENCE & SKILLS

Technical Skills

• 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.

Professional & Interpersonal Skills

• 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.

SOFT SKILLS

• Strong critical-thinking skills.

• Excellent communication and interpersonal skills.

• Ability to present effectively and collaborate across business functions.

SUMMARY

The Specialist IS (Pi Data Historian) plays a vital role in ensuring that Amgen's Manufacturing Information Systems remain robust, compliant, and aligned with business needs. This position blends technical expertise, leadership, and collaboration to support manufacturing reliability, efficiency, and innovation.

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