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.
Requirements
Basic requirements
Bachelor's degree in IT, Computer Science, Engineering, or equivalent years of experience.
10+ years in IT architecture, solution design, or technical leadership in Life Science Manufacturing, including multiple end-to-end MES deployments.
8+ years hands-on expertise in PharmaSuite, Syncade (or an equivalent MES), including MBR/recipe design, master data, configuration, and integration.
Strong working knowledge of GMP requirements, data integrity principles, and Computer System Validation.
Additional skills and preferences
Experience working globally, influencing without authority, and resolving complex cross-functional issues.
Demonstrated experience establishing standards, templates, or reference architectures adopted across multiple sites or business units.
Strong communication skills with both business and IT experts.
Familiarity with integration patterns and adjacent platforms such as ERP, LIMS, historians, and shop-floor automation.
Experience with MES master data governance, data migration, and ERP synchronization.
Knowledge of release management, environment strategy, and configuration management for validated systems.
Knowledge of business process development, SOPs, governance processes, and program management.
Risk-based decision making, learning agility, and subject matter expertise in Life Sciences.
Strong vendor and account management skills, including the ability to hold partners accountable to technical standards.
Ability to coach and develop others, and to translate complex technical standards into practical guidance for delivery teams.
Additional Information
Position location: Indianapolis, Indiana.
Occasional off-hours and weekend work is expected, particularly around go-lives, upgrades, and releases.
15-20% domestic and international travel is expected,.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
- Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
- $144,000 - $231,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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