MES Systems Engineering - Sr. Principal

Summary

The MES System Engineer - Sr. Principal owns the technical integrity, standardization, and long-term health of the PharmaSuite solution that underpins the Next Generation Manufacturing Execution System (PharmaSuite and Syncade). This role sets the standards in process and technology that every site deployment inherits and sustains them as the platform scales, so that sites deploy faster, with less rework, on a common and validated foundation.

Key Responsibilities

Cross-site standardization

• Drive standardization of manufacturing processes across sites, defining a common process model and a controlled path for site-specific variation.
• Define and maintain the global MES template: a standard configuration baseline that sites adopt, extend only through governed exceptions.
• Partner with Technical Services & Manufacturing Technology (TS/MS), Process Engineering, Operations and Quality to align site processes to the standard before and during deployment and during steady state support and ongoing continuous improvement changes.
• Evaluate site requests for deviation from the standard, weigh them against cost, validation impact, and long-term supportability, and decide or escalate.

MBR / EBR design and development best practices

• Establish and sustain the standards for Master Batch Record development: recipe and phase structure, reusable components, naming conventions, UI and operator-experience patterns, and design review criteria.
• Own the Global library of reusable, validated building blocks (phases, operations, and templates) and the rules for when and how they are reused or extended.
• Define the MBR development lifecycle, including peer review, design checkpoints, testing expectations, and handoff to validation, in alignment with the global delivery process.
• Coach Platform Architects and delivery partners on the standards, and review MBR designs for compliance, quality, and maintainability.

Master data management

• Define and govern the master data model for MES Systems: materials, equipment, units of measure, work centers, resources, and the recipe-related data that drives them.
• Establish master data ownership, quality rules, change control, and synchronization approaches with ERP and other source systems.
• Develop data migration and data readiness standards so that each site deployment starts from clean, consistent, validated data.

Technical ownership

• Define integration architecture and standards with adjacent platforms (for example ERP, LIMS, equipment and automation layers, historians, and quality systems) in collaboration with the SMEs of those platforms.
• Lead technical design of platform-level enhancements, custom extensions, and reusable accelerators, and manage the technical relationship with the platform vendor and delivery partners.
• Set non-functional standards for performance, scalability, resilience, security, and data integrity, and ensure the platform remains compliant with GMP and data integrity expectations.
• Drive technical root-cause analysis and resolution of complex, cross-site platform issues.

Governance and enablement

• Chair or contribute to design authority and architecture governance forums, and maintain the standards, patterns, and decision records they produce.
• Partner with Platform Architects, Implementation Leaders, Site IT Leaders, and Support Team Leaders to build platform knowledge, including training, playbooks, and communities of practice, and to prepare support teams for sustained operation.
• Measure and report on standardization and adoption, such as template conformance, reuse rates, deviation counts, and defect trends, and use the results to drive continuous improvement.
• Identify and champion innovations that accelerate delivery and lower the total cost of ownership of the platform.

Key Objectives / Deliverables

• A governed global PharmaSuite and Syncade templates and standards catalog that every new site deployment starts from.
• A GAP process to manage differences between sites operational process and the global standard process.
• A published MBR development standard, reusable component library, and design review process in active use by all delivery teams.
• A master data model, ownership framework, and data readiness standard applied consistently across sites.
• A platform architecture roadmap covering environments, releases, upgrades, and integrations, aligned with program and site timelines.
• A reusable, risk-based validation approach that reduces per-site validation effort without weakening compliance.
• A standardization scorecard (template conformance, reuse, deviations, defect trends) reviewed regularly with program leadership.
• Upskilled Solution Architects, delivery partners, and site support teams who can apply and sustain the standards independently.