Sr Mfg Systems Engineer - MES

Sr Manufacturing Systems Engineer – MES (Amgen India, AIN)

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.

Role Summary

The Sr Manufacturing Systems Engineer – MES is a technical leader responsible for lifecycle upgrades, maintenance, and optimization of MES systems across Amgen’s global manufacturing network. This role is part of the MES Center of Excellence (COE) at Amgen India (AIN), supporting all manufacturing sites and enterprise MES infrastructure. The engineer will collaborate with cross-functional teams to ensure reliable data collection, integration, and analytics for manufacturing operations, driving digital transformation and operational excellence.

Key Responsibilities

• Lead lifecycle upgrades, migrations, and enhancements of MES systems across Amgen manufacturing sites.
• Serve as a technical SME for MES, supporting Core and site MES infrastructure and ensuring high availability, performance, and compliance.
• Collaborate with global manufacturing, automation, and IT teams to design, implement, and validate MES solutions for data acquisition, integration, and reporting.
• Develop and maintain documentation, standards, and best practices for MES system architecture, security, and data governance.
• Troubleshoot and resolve complex MES system issues, providing advanced support to end users at the sites.
• Drive continuous improvement initiatives, leveraging MES data for process optimization, predictive analytics, and digital manufacturing projects.
• Participate in global MES COE activities, knowledge sharing, and training for site teams.
• Ensure compliance with regulatory requirements and Amgen’s quality standards in all MES system activities.
• Support audits, validation, and change management processes related to MES systems.
• Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgen’s business objectives and digital transformation initiatives.
• Help to define and enforce best-in-class standards, methodologies, and governance for MES architecture, integration, cybersecurity, data integrity, and regulatory compliance (e.g., GxP, CFR Part 11).
• Drive harmonization of MES business processes and technical implementations across global sites, leveraging ISA-95 and other relevant manufacturing standards.
• Guide the evaluation and adoption of emerging technologies (e.g., IIoT, data lakes, AI/ML, containerization) to enhance MES capabilities and support advanced manufacturing use cases.
• Implement and support the solution architecture, design, deployment, and lifecycle management of NextGen MES platforms—with a focus on PAS|X, SAP integration, automation interfaces, and cloud adoption—across all manufacturing sites.
• Foster a culture of innovation, knowledge sharing, and continuous improvement within the COE and the wider global MES community.
• Ensure comprehensive documentation, knowledge management, and training programs to support global system adoption and sustainability.
• Champion change management strategies to enable successful MES transformation and adoption at all levels of the organization.

Basic Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (or Master’s degree with relevant experience).
• 8+ years of experience in manufacturing systems engineering, with 3+ years focused on MES or similar industrial data platforms.
• Hands-on experience with MES System lifecycle management, upgrades, and enterprise deployments.
• Hands-on experience with MES solution architecture, deployment, and lifecycle management in a GMP-regulated pharmaceutical, biotechnology, or manufacturing environment.
• Extensive experience with PAS|X MES (including v3.3 or higher), SAP integration, and Level 2/3 automation systems.
• Proven track record leading global, multi-site MES transformation programs, including direct management and mentorship of technical teams.
• Deep understanding of GxP regulations, CSV/CSA, and SDLC best practices.
• Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes).
• Excellent communication, relationship-building, and stakeholder engagement skills.

Preferred Qualifications

• Expertise with Korber PAS|X MES, including eBR, Equipment Management, Weigh & Dispense, etc.
• Familiarity with international MES standards (ISA-95, GAMP, etc.).
• Experience representing MES programs with regulatory agencies and external partners.
• Experience with SAP MES integration and automation platforms (Rockwell, DeltaV, OPC UA, Pi).
• Proficiency with modern data platforms (PostgreSQL, data lakes, data fabric) and containerized application deployment (e.g., Kubernetes).
• Professional certifications (MES, SAP, Project Management/PMP, or equivalent).

Work Environment

Onsite at Amgen India (Hyderabad) with collaboration across global time zones.
Participation in global MES COE meetings, lifecycle planning, and major upgrade events; occasional extended hours to support global coordination as needed.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.