Shiva Prasad Bomminayini

MES Engineer @ Kenvue

About

As an experienced MES Engineer, I design, implement, and support end-to-end Manufacturing Execution System solutions that help global manufacturers digitalize operations, ensure compliance, and drive operational excellence. With hands-on expertise across pharmaceutical, medical device, automotive, and energy industries, I bring deep technical knowledge in MES configuration, deployment, workflow design, ERP/automation integration, and regulatory validation (GMP, FDA, ISO, 21 CFR Part 11). I’m passionate about transforming complex production processes into smart, data-driven systems—optimizing efficiency, traceability, and quality at every stage of manufacturing. My experience includes collaborating with cross-functional global teams, leading MES implementations, and supporting continuous improvement initiatives aligned with business and compliance goals.

Country

City

United States

Industry

Computer Software

Skill

MES, Aveva, Pharmasuite, Opcenter, Validation (Drug Manufacture), AutoCAD, DeltaV, SAP Implementation, PLM Tools, Manufacturing Process Improvement, AutoCAD Mechanical, SAP FICO, SAP ME/MI, SAP ERP, Laboratory Information Management System (LIMS), Teamcenter, Tulip, JavaScript, Natural Language Processing (NLP), SCADA

Experience

MES Engineer

Kenvue

2026-2 - Present · 8 mos

Lititz, PA

MES Consultant

Pfizer

2023-9 - Present · 3 yrs 1 mo

New York, United States

Led the technical architecture and implementation of MES for a global pharmaceutical site migration. Designed and configured electronic batch record workflows, integrated MES with SAP, LIMS, and SCADA, and ensured full compliance with GxP and FDA 21 CFR Part 11. Developed validation strategies, reduced batch close times by 75%, and delivered operator training programs to boost first-pass adherence. Supported regulatory audits with zero critical findings and drove continuous improvement initiatives across manufacturing operations.

Senior MES Engineer

Ford Motor Company

2021-8 - 2023-8 · 2 yrs 1 mo

Dearborn, Michigan, United States

Directed the enterprise rollout of MES across multiple automotive assembly plants. Led end-to-end MES implementation, process optimization, and integration with ERP and shop floor automation. Standardized workflows for serial tracking and genealogy, reducing warranty trace times from days to minutes. Implemented automated work order dispatch, improved takt adherence, and reduced WIP by 18%. Mentored junior engineers and championed digital transformation and Industry 4.0 best practices.

MES Functional Consultant

SUN PHARMA

2019-5 - 2021-3 · 1 yr 11 mos

Baroda, Madhya Pradesh, India

Implemented MES for manufacturing and packaging operations in a GMP-regulated OSD facility. Designed and configured Electronic Batch Records (EBR), material dispensing workflows, and master recipes aligned with ISA-88/ISA-95 standards. Integrated MES with SAP ECC (PP/QM) and DeltaV DCS for automated batch execution and material reconciliation. Supported IQ/OQ, validation documentation (URS, FRS, PQ), and FDA 21 CFR Part 11 compliance. Implemented review-by-exception logic, reducing QA batch review time by 40%, and provided go-live hypercare and user training.

MES Integration Engineer

ReNew

2018-3 - 2019-4 · 1 yr 2 mos

Hyderabad, Telangana, India

Delivered MES integration for a power generation client, capturing production events and OEE across turbine and plant equipment. Configured and maintained MES modules, automated maintenance work order generation, and improved planned maintenance ratios. Built Power BI dashboards for real-time operational insights and implemented edge-device strategies to enhance data reliability and meet uptime SLAs. Collaborated with cross-functional teams to align MES functionalities with business needs.

Education

Maryville University of Saint Louis

Data Science

2021 - 2022 · 1 yr

Completed a comprehensive curriculum focused on both theoretical foundations and practical applications of data science. Key coursework included: •Programming & Data Tools: R Programming, Python, SQL • Machine Learning & Modeling: Machine Learning, Predictive Modeling, Deep Learning • Big Data & Advanced Topics: Big Data Analytics, Text Mining, Experimental Design, Mathematical Modeling • AI & Modern Applications: ChatGPT and Generative AI • Data Communication: Data Visualization Developed strong analytical, programming, and problem-solving skills with hands-on experience in real-world data science projects.