What you will do This strategic leadership role is accountable for building, managing, and evolving the global MES COE, overseeing MES and adjacent systems deployments, lifecycle management, and governance for all manufacturing sites across Amgens network.
As the Sr Manager, you will direct a high-performing team of MES engineers, and technical specialists, ensuring the effective delivery and continuous improvement of MES solutions. You will partner with cross-functional leaders in Digital, Technology & Innovation, Operations, Quality, IT, and Automation to drive Amgens NextGen MES strategyfrom vision through executionsupporting seamless integration with SAP, automation, cloud, and data platforms.
Your leadership will ensure standardization, compliance, and technical excellence, enabling Amgens digital transformation and operational agility on a global scale.
Roles & Responsibilities - Lead and manage the global MES Center of Excellence (COE), including strategy, team building, performance management, and talent development.
- Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgens business objectives and digital transformation initiatives.
- Establish 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.
- Oversee the solution architecture, design, deployment, and lifecycle management of NextGen MES platformswith a focus on PAS|X, SAP integration, automation interfaces, and cloud adoptionacross all manufacturing sites.
- Serve as a steering member and customer concern point for all major MES projects, system incidents, and strategic vendor relationships.
- Develop and manage COE resource plans, budgets, and external partnerships to meet organizational objectives.
- 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.
- Represent Amgen MES strategy and practices to senior leadership, regulatory agencies, and external partners as required.
Basic Qualifications:
- Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years Engineering, Computer Science, Information Systems, or a related field.
- Minimum 8 years of 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/validation, and SDLC standard methodologies.
- Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes).
- Strong financial and vendor management experience.
- Excellent communication, relationship-building, and collaborator engagement skills at all levels, including executive leadership.
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).
Soft Skills - Visionary leadership with a passion for nurturing technical talent and high-performing teams.
- Strategic thinking, adaptability, and a growth mindset.
- Exceptional organizational, analytical, and problem-solving abilities.
- Resilience in a dynamic, fast-paced, and global environment.
- Commitment to diversity, inclusion, and fostering a collaborative culture.
