Associate IS Engineer MES

Role Description:

In this crucial role on the Amgen MES team, you will install, upgrade, support and maintain the MES application that meet business needs while ensuring system availability and performance. You will collaborate with stakeholders including Operations, Quality, Automation, IT, and global business stakeholders to ensure MES solutions align with strategic goals and user needs. Create and maintain scalable solutions on the Amgen MES Platform, monitor system health, and respond to incidents to minimize downtime.

Roles & Responsibilities:

• Collaborate with business and data stakeholders to gather requirements, assess data needs, and ensure data integrity and compliance across ETL pipelines.
• Lead day to day operations and maintenance of Amgens MES Platform and hosted applications.
• Stay updated with the latest trends, advancements and standard process for MES Platform ecosystem.
• Analyze and understand the functional & technical requirements of applications, solutions and systems, translate them into software architecture and design specifications.
• Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software following IS change control and GxP Validation process while exhibiting expertise in Risk Based Validation methodology.
• Work on integrating with other systems and platforms to ensure seamless data flow and functionality.
• Stay up to date on MES Features, new releases and best practices around MES Platform Governance.
• End-to-end design, configuration, and implementation of Amgens NextGen MES, with a focus on PAS|X platform technical deployments.
• Serve as the technical support for PAS|X MES implementations, including requirements gathering, solution architecture, interface design, and system validation.
• Contribute through all project phasesdesign, build, test, deployment, and hypercareensuring delivery commitments are met.
• Ensure technology strategies for MES system enhancements, scalability, and cloud readiness, supporting Amgens digital transformation journey.
• Develop and deliver clear documentation, including functional/technical specifications, validation protocols, and training materials.
• Troubleshoot on MES technical challenges, incident response, and root cause analysis.

Basic Qualifications and Experience:

• Masters or bachelors degree and 0 -1 year of Information Systems experience or related field OR

• Associates degree and 2+ years of Information Systems experience or related field

Functional Skills:

• 2-5 years of experience working in global pharmaceutical Industry
• Experience in building solutions on an MES Platform.
• Experience in managing systems, implementing and validating projects in GxP regulated environments.
• Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and managing change controls.
• Hands-on experience implementing and supporting PAS|X MES in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Technical expertise in MES solution design, configuration, and integration with SAP (PP, QM, MM modules), and Level 2 automation systems (e.g., PLCs, SCADA, DCS, OPC).
• Experience with IT/OT cybersecurity, data integrity, and cloud-based MES architectures is highly desirable.
• Strong skills in technical documentation, stakeholder engagement, and cross-functional communication.

Good-to-Have Skills:

• Experience with PAS|X MES advanced modules (eBR, Equipment Management, Weigh & Dispense, Master Batch Record configuration).
• Experience integrating MES with SAP S/4HANA and/or advanced automation/data platforms.
• Familiarity with ISA-95 standards, data lakes, and supporting digital manufacturing initiatives (e.g., IIoT, AI/ML for manufacturing data).
• Experience working across global, matrixed teams and/or as a technical leader for external vendors/partners.
• Experience with containers / Kubernetes and databases (Oracle / PostgreSQL)
• Outstanding written and verbal communication skills, and ability to translate technical concepts for non-technical audiences.

Soft Skills:

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.