Detail-oriented System Support Specialist with a strong background in technical support and system troubleshooting. Proven ability to enhance user experiences and streamline operations within cryptocurrency platforms.
Overview
6
6
years of professional experience
Work History
Pi System Engineer
Eltresis
Los Angeles
06.2021 - 07.2024
Ensured full GxP compliance across OSIsoft/AVEVA PI System deployments, including data integrity, audit trails, user access controls, and adherence to FDA and EMA guidelines.
Supported systems and workflows aligned with 21 CFR Part 11 requirements, including electronic records/electronic signatures (ERES), identity verification, audit trails, and secure authentication.
Worked with QA, validation, and compliance teams to maintain ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate), ensuring high data integrity in manufacturing environments.
Performed Computer System Validation (CSV) using Veeva, HP ALM, and Kneat for change controls, deviations, test scripts, and documented evidence in accordance with GAMP 5 standards.
Configured PI System security (Windows authentication, mappings, trusts), ensuring controlled access, segregation of duties, and proper electronic signature authorization workflows.
Created validated PI AF models, event frames, calculations, and notifications used for batch monitoring, cleanroom environmental data, utility systems (WFI, HVAC), and equipment performance tracking.
Produced compliant PI Vision dashboards and Datalink reports for QC, QA, manufacturing, and MS&T teams, with regulated and non-regulated environment segregation.
Supported audits and inspections (internal, FDA, and third-party), provided documentation, system logs, and traceability matrices demonstrating compliance and system reliability.
Managed deviations, CAPAs, change requests, and risk assessments following pharmaceutical SOPs and quality management systems.
Ensured PI data integrity and availability for Batch Release, electronic batch records (EBR), and real-time monitoring of critical process parameters (CPPs) and critical quality
Systems Analyst
Conduent
Istanbul
01.2018 - 05.2020
Supported manufacturing operations by analyzing system data and optimizing automation workflows using the OSIsoft/AVEVA PI System for real-time monitoring, reporting, and root-cause analysis.
Developed and improved process control dashboards, data models, and alerts to enhance production visibility and reduce downtime across plant systems.
Collaborated with engineering and automation teams to integrate PI System data streams with process control systems, improving decision-making and operational efficiency.
Troubleshot system issues by reviewing PI tags, interfaces, and datasets, ensuring accurate data flow between PLCs, SCADA systems, and enterprise applications.
Leveraged PI System tools (PI Vision, PI AF, and Event Frames) to analyze production trends, identify bottlenecks, and recommend automation improvements for manufacturing operations.
Documented system changes, supported digital transformation initiatives, and helped standardize best practices for data-driven process optimization.