Enzo S. Lihard Email & Phone Number

Louisville, Ky, Us

Tarrytown, New York, Us

I have led optimization efforts through data governance, aligning with Process Data Criticality to drive continuous improvement. I have overseen software validation for enterprise systems, ensuring robust data collection, redundancy, and alarm management. Additionally, I have designed and implemented new Data Criticality Programs, enhancing data management and integrity. My work also includes supporting Risk-Based Engineering by optimizing HMI and OSI Pi configurations, as well as leveraging extensive knowledge in PLC programming to improve process efficiency.

Louisville, Ky, Us

Lawrence Township, Nj, Us

As an SME Data Architect at Bristol-Myers Squibb, I focused on automating and enhancing the Continued Process Verification (CPV) using advanced analytics and ML algorithms. I developed and executed comprehensive validation plans and conducted Big Data analysis to provide business intelligence solutions, uncovering hidden insights and enhancing process control. My efforts ensured robust design verification, real-time monitoring, and compliance with global standards, significantly advancing the company's process validation and quality assurance capabilities.

Bloomington, Indiana, Us

At Cook Medical, I led remediation efforts within the Quality Management System (QMS) by identifying optimization pathways and collaborating with cross-functional teams to validate processes and ensure equipment management compliance. I played a key role in developing and validating test methods for manufacturing products, executing key validation protocols, and conducting critical reviews of documentation such as pFMEA and dFMEA. My work ensured the traceability and integrity of manufacturing processes, directly impacting product quality and compliance.

Irvine, Ca, Us

As a Senior Quality Validation Engineer at Edwards Lifesciences, I led testing initiatives for internal and external-facing applications, establishing a robust quality framework and automation strategy. I authored and executed validation protocols, managed deviations, and oversaw the entire product lifecycle. Additionally, I conducted ALCOA assessments and validated documentation for PLCs, ensuring adherence to FDA regulations and industry standards for Computer System Validation (CSV).

Caguas, Pr, Pr

I managed the validation lifecycle for the serialization of a packaging line at Amgen’s Louisville Distribution Center. My responsibilities included LDC Characterization, commissioning, qualification activities, and managing SAP/MES infrastructure testing. I also provided extensive experience in serialized data exchange and served as a CSV Consultant for continuous monitoring procedures, ensuring data integrity and compliance.

Us

As a Senior Validation Engineer at Johnson & Johnson (McNeil), I was responsible for the validation lifecycle of packaging operations, aligning deliverables with McNeil’s consent decree working plan. I managed customer projects, ensuring delivery dates and quality standards were met, and provided technical support to the packaging operations team. My role was pivotal in coordinating technical support activities and ensuring seamless project execution.

Ontario, Ca, Us

At SIGMAnet, I served as a Senior Systems / Sales Engineer, providing pre- and post-sales support and consultancy for hardware and software solutions. I managed the migration of local storage systems to Dell EqualLogic arrays, ensuring successful validation across multiple international sites. My work increased the redundancy and reliability of production systems, directly contributing to the stability and efficiency of operations.

Indianapolis, Indiana, Us

At PACIV, I led a team of engineers within Eli Lilly's R&D Department, where I coordinated the design, installation, programming, and startup of a new medical device assembly line. I also provided critical technical support, implemented risk evaluation procedures, and ensured compliance with regulatory requirements through rigorous validation and audit processes.

New York, New York, Us

As a Senior Automation / Validation Engineer at Pfizer Pharmaceuticals, I provided technical support in fault-finding situations, implemented comprehensive backup and disaster recovery procedures, and conducted audits of the Building Management System (BMS) to ensure compliance with FDA and MHRA standards. My work specialized in resolving hardware and software discrepancies and ensuring ongoing operations were compliant with GMP practices.

At GlaxoSmithKline, I led a team in managing control automation and data acquisition systems for packaging lines. My responsibilities included supporting the validation and qualification lifecycle for new equipment, ensuring all processes met FDA and MHRA regulatory requirements. I also provided technical support to engineers, minimizing downtime and proactively evaluating risks to ensure efficient operations.

Indianapolis, Indiana, Us

At Eli Lilly, I held multiple roles as a Senior Automation / Validation Engineer, where I was responsible for PLC code changes, CSV documentation remediation, and the execution of retirement plans for automation equipment. I led projects involving control systems for packaging lines, utilities, and inspection equipment, ensuring compliance with global standards and driving continuous improvement in system reliability and efficiency.

Switzerland 🇨🇭 , Ch

As an Automation / Validation Engineer at Roche Diagnostics, I led a team responsible for the CSV lifecycle of product lines, including the validation of automated medical device production and packaging lines. My role included leading the qualification of lab equipment and ensuring compliance with regulatory standards, contributing to the successful integration of critical systems.

Bristol-Myers Squibb / Simmer Caribbean / Colgate-Palmolive In various roles with Bristol-Myers Squibb, Simmer Caribbean, and Colgate-Palmolive, I led the design, installation, and startup of control systems for chemical tanks, HVAC systems, and other critical infrastructure. My work involved managing point-to-point verifications, sequence verification, and optimizing control systems operation, ensuring compliance with industry standards and enhancing system efficiency.

Roma, Lazio, It

Government Agency; Military industryDuring my service in the Aeronautica Militare, I served as a System Administrator for the IBM S/9370 Calculator, managing a VM/CMS operating system and SQL database within a LAN environment. Additionally, I acted as a Network Administrator, where I designed and configured client-server networks, contributing to the IT infrastructure of a government agency within the military industry.

Bs, Software Engineer

Master'S Degree

Diploma In Information Technology, Information Technology

Ba, Business Administration

Education record