New York City Metropolitan Area
25+ years' experience of deep domain convergence across Life Sciences, Engineering, Computer Systems, and Advanced Technology Systems within the GxP, pharmaceutical, biotechnology, and chemical engineering sectors. Expertise in computerized systems validation (BMS, CRM, SCM, ERP, QMS, LIMS, MES, MIS), quality information and GxP enterprise technology platforms supporting global operations. Experienced in quality systems, regulatory compliance, and FDA-regulated environments, ensuring alignment with cGMP, GAMP, and global regulatory frameworks. Extensive experience overseeing validation, serialization, automation, scientific data analysis, and regulated digital infrastructure across manufacturing, laboratory, and supply chain systems. Committed to lifelong interdisciplinary learning with degrees in Engineering, Technology, Life Science and Physical Sciences, with concentrations in Biotechnology, Chemical Engineering, Biological Engineering, Information Systems and Management, integrating chemistry, biology, and computational technologies to support innovation and compliance in regulated industries. 8+ years in Global Medical Missions. Core Competencies: Leadership and Operations: Management, Administration, and Technical Supervision Biological and Laboratory Sciences: Microbiology, Aseptic Processing, Forensic Science Research and Laboratory Operations Biologics and Biochemical Systems Engineering and Process Technologies: Electrical and Process Engineering Process Automation and Analytical Technology Process Safety Management Aseptic Manufacturing Digital Systems and Technology: Computer Systems and Enterprise Platforms Serialization and Track-and-Trace Systems Technical Services and Digital Infrastructure Environmental and Industrial Systems: Environmental and Industrial Engineering Monitoring and Compliance Chemical Sciences: Chemistry and Chemical Engineering Process Chemistry and Pharmaceutical Engineering Biological and Computational Sciences: Biotechnology and Bioengineering Bioinformatics and Computational Biology GxP Compliance and Validation: Quality Systems and Validation Lifecycle Computer Systems Validation (CSV) / CSA Quality, Compliance, and Data Systems: GxP Manufacturing (cGMP, GLP, GCP, GDP) Data Integrity and Data Governance Regulatory Compliance Global Supply Chain Engineering: Logistics and Trade Compliance Dangerous Goods and Multimodal Transportation Scientific Communication: Technical/Scientific Writing Advanced Analytics: Predictive/Prescriptive/Diagnostic/Descriptive Analytics Data Integration/Statistical Analysis ANOVA/MANOVA MATLAB/Scientific Computing Anylogic
Responsible for overseeing the strategic development and alignment of computer systems validation activities and CSV personnel related to GxP computerized systems, serialization and technology within Sharp Global inclusion. Management and utilization of a system development lifecycle (SDLC) approach and application of industry guidance (GAMP 5) in accordance with 21 CFR Part 11 requirements. Executes comprehensive verification strategies across on-premise infrastructure and SaaS application architectures. Validates system reliability through functional, integration, regression, and vendor-release testing while ensuring continuous data integrity via strict adherence to ALCOA+ principles, objective evidence generation, and robust lifecycle documentation. Team leadership and technical oversight, team development, hiring, goal setting, workload and resource allocation. Directly manages, reviews and approves the work of the CSV team. Guide technical decisions and best practices to ensure quality and compliance standards and audit readiness for internal and regulatory audits. Improvement of process and performance. Identify areas of improvement, participate in Kaizen, project meetings and workflow development of new and existing computer systems, hardware, software, configuration, and disaster recovery. Collaborates with engineering teams, project managers, regulatory agencies, quality, and customers. Combines deep scientific and engineering expertise with strong critical thinking and team leadership skills. Applies collaborative problem-solving to consistently meet daily production targets and long-term project deliverables. Bridges the gap between chemistry, engineering, technology, manufacturing, quality, regulatory compliance, supply chain and computer systems to meet the business needs. 2022- 2025 -IT/Business Portfolio/Technology and Corporate Development, CSV Supervisor 2019-2022, Electrical Engineering and Controls, CSV Engineer ACS, ISPE, IEEE
Contract for Computerized Systems Validation at Sharp, part of UDG Healthcare.
Pharmaceutical Engineering and Manufacturing/R&D Validation under the Engineering and Systems group GxP, Assessments, IOPQ, Automation, Kiosk, High Sheer Granulation, Tablet Press, Liquid and solid dosage.
Chair for the science, engineering and architecture group while working on the Global Medical Missions Team for planning, implementation and execution of the missions first Medical Clinic in Machakos Kenya (Global Hope International).
Senior Chemical Engineering and Technology Leader with more than 20 years of experience directing compliance, testing, and regulatory strategy across highly regulated industries. Recognized for building and leading technical programs that integrate analytical chemistry, process engineering, regulations, and advanced monitoring technologies to ensure operational compliance and regulatory approval. Expert in the design and execution of complex air emissions testing and monitoring programs, including isokinetic and non-isokinetic source testing, continuous emissions monitoring systems, and advanced analytical methodologies. Proven ability to translate regulatory requirements into practical engineering and operational solutions, guiding organizations through state and federal compliance frameworks, Title V permitting and regulations with 40 CFR Parts 51, 60, 61, 63, and 75. Extensive experience developing and negotiating regulatory protocols and approvals directly with agencies, achieving consistent pre-test and final report approvals while maintaining full transparency within the public regulatory record. Known for successfully managing complex testing programs from design through execution, data validation, and regulatory reporting. Technical expertise spans industrial emissions testing, chemistry, process analytical control equipment, metals analysis, GC/HPLC, FTIR, particulate, and dioxin/furan analysis, supported by advanced instrumentation platforms including DAS, DCS, PLC, RTU, PAC, and mobile labs. Led implementation and validation of the EPA Electronic Reporting Tool and electronic compliance reporting programs. Industry experience includes emissions and compliance programs across energy generation, industrial manufacturing, petroleum terminals, printing and food processing facilities, wastewater treatment plants, incineration systems, vapor recovery and combustion units, biosolids processing, boilers, turbines, scrubbers, oxidizers, SCR and ESP systems.