NAVATEJA GAJULA
Bothell
Summary
Strategic MES Architect and Senior Manager with over 13 years of experience in leading Manufacturing Execution System (MES) strategy and architecture in pharmaceutical and GMP environments. Expertise in defining IT architecture roadmaps, advancing Syncade platform innovation, and integrating MES solutions with enterprise data and cybersecurity. Skilled in S95/ISA-95 architectures and lifecycle management, with a strong track record of influencing stakeholders and delivering compliant MES solutions that enhance global manufacturing operations.
Overview
15
15
years of professional experience
Work History
Sr Manager MES IT
Bristol Myers Squibb
Bothell
09.2023 - Current
- Managed multiple IT projects and ongoing work activities of moderate to high complexity, ensuring timely completion.
- Lead short‐term and long-term IT projects according to established policies and procedures.
- Collaborated with IT organization to resolve manufacturing system issues through review, planning, building, testing, documentation, and implementation of design changes.
- Supervised MES engineers to ensure optimal system performance and up-time.
Sr Engineer MES
Bristol Myers Squibb
Bothell
09.2020 - 09.2023
- Led upgrade projects including Syncade WF49 and implemented InfoBatch reporting tool using .Net, C#, SQL to enhance reporting capabilities.
- Supporting MES systems, optimization, upgrades, customization and leading the team of four Engineers as a technical system owner.
- MES systems development, scripting, implementation, support software and hardware life cycle management efforts to maintain systems.
- Scope development, qualification, functional specs review and coordination with system integrator to ensure software deliverables align with corporate automation standards from detail design specifications.
- Created and assigned user stories to the team during sprint planning, following agile methodology.
- Created custom reports in InfoBatch to extract supplemental electronic health records and robust business intelligence.
- As an MES SME, assessing the impacts on MES code objects for multiple markets launches, integrations, and upgrades.
- Supported plant operations on-call to assess discrepant events and delivered solutions for floor support, ensuring safety and quality compliance.
- Coordinated with vendors to ensure systems aligned with site requirements and operational needs.
MES APPLICATION DEVELOPER
Envision InfoSolutions Inc.
Oceanside
06.2016 - 09.2020
- Developed Syncade recipes using Recipe Authoring and established electronic Logbook, Master BOM Editor, AgileDoc, Sub Unit Editor, and Recipe Formula Exchange (between DeltaV PCS and Syncade MES) web parts utilizing .Net framework web development.
- Created and distributed custom tools, Crystal Reports, and web reports with user-friendly GUI interfaces, leveraging SQL Management Studio for queries and stored procedures to enhance reporting capabilities.
- Managed change control processes including URS, FS, DDS, CMG, Trace Matrices, IQ, OQ, and PQ for the Systems Automation group, ensuring compliance and system integrity.
- Validated software systems in cGMP and non-GMP environments to ensure regulatory compliance.
Jr Engineer
Zetatek Industries Ltd
Hyderabad
06.2011 - 12.2014
- Designed solution architecture; performed requirements analysis and presented project team with new scenarios and business perspectives for complex cross-functional projects.
- Managed source code versions to ensure accuracy and consistency.
- Assisted in designing and testing mechanical components for industrial applications.
- Collaborated with senior engineers to improve product designs and specifications.
- Conducted routine maintenance on equipment to ensure operational efficiency.
Education
Master of Science - Computational Science
Texas A&M University
Commerce, TX05.2016
Skills
- MES Architecture & Roadmap DesignSyncade MES (Configuration, Recipes, Upgrades)S95/ISA-95 Level 3 ArchitectureIT Strategy & Business Case DevelopmentCybersecurity Governance for MES SystemsGlobal IT Delivery & Support ProcessesCross-Functional Stakeholder ManagementData Architecture AlignmentProof-of-Concept Design & FacilitationGMP / Pharma Regulatory ComplianceSystem Integration & Interface DesignTeam Leadership, Coaching & MentoringSDLC, Agile, Change Control (CR/CAPA)Microsoft SQL Server / InfoBatch ReportingHyper-V, VMware, VirtualizationC#, VB Script, Java, ASPNET, XML/XSLTServiceNow, ValGenesisURS, FS, DDS, CMG, IQ/OQ/PQ Validation
- Project management
- Manufacturing execution systems
- Software development
- Data analytics
Timeline
Sr Manager MES IT
Bristol Myers Squibb
09.2023 - Current
Sr Engineer MES
Bristol Myers Squibb
09.2020 - 09.2023
MES APPLICATION DEVELOPER
Envision InfoSolutions Inc.
06.2016 - 09.2020
Jr Engineer
Zetatek Industries Ltd
06.2011 - 12.2014
Master of Science - Computational Science
Texas A&M University