Specialist Business Analyst (Pi Data Historian)

Amgen Inc. (IR); Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Amgen India seeks a Specialist Information Systems (Pi Data Historian) to own, administer, and lead OSI Pi and related manufacturing information systems in a GMP-regulated setting. You will integrate with process equipment, design data collection, and enable robust visualization, trending, and analytics for manufacturing operations.

Collaboration with Automation, Engineering, Operations, Quality, and IS teams is essential, along with driving system improvements, validation, and disaster recovery

Qualifications

• - Bachelor's degree in Engineering, Information Systems, Computer Science, or Life Sciences.
• - 8+ years of experience with a minimum of 5 years 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.

Responsibilities

• 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 policies, procedures, and regulatory expectations.
• 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 and coach users on compliant use.

Skills

Customer relations

Communication

Problem-solving

Decision-making

Independent work

Multitasking

Education

Bachelor's degree in Engineering/IS/CS/Life Sciences

Tools

OSI Pi

RtReports

SQL

PLC/DCS/SCADA

Instrumentation

Validation

Data analytics

Job description

Career Category Information Systems Job Description - Specialist Information Systems (OSI Pi Data Historian)

About Amgen Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what's known today.

About the role Role Title: Specialist Information Systems (Pi Data Historian) Location: Amgen India.

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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen