Sr Manufacturing Systems Engineer – Mes, Oee

Career Category Information Systems Sr Manufacturing Systems Engineer - MES OEE Scheduling 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 The engineer will also lead and support the finite production scheduling and overall equipment effectiveness tools at Amgen Key Responsibilities Lead lifecycle upgrades migrations and enhancements of MES systems across Amgen manufacturing sites Lead lifecycle upgrades migrations enhancements and support of finite production scheduling and overall equipment effectiveness 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 Experience working with finite production scheduling e g VirtECS or SAP scheduling module and overall equipment effectiveness Korber s PAS-X KPI tools at Amgen 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