Gemma Sobieraj
Commissioning & Qualification Engineer @cGMP Consulting Inc.
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WORK HISTORY
Commissioning & Qualification Engineer @cGMP Consulting Inc.
Eli Lilly Kenosha County, WI, US
Support commissioning and qualification activities for a large-scale greenfield pharmaceutical site expansion, supporting administrative, utilities, and laboratory facilities- Draft and execute IQ/OQ/PQ protocols, traceability matrices, and validation documentation for critical utilities, equipment, and automated systems- Execute validation activities in parallel with ongoing construction, coordinating with engineering, facilities, quality, and external vendors to support phased system readiness- Drive continuous improvement in C&Q processes by developing standardized documentation and execution approaches across the expansion project- Gain hands-on exposure to large-scale project execution, documentation governance, and risk management in a regulated environment.
EDUCATION
University at Buffalo
Professional Master of Business Administration - MBA
Rochester Institute of Technology
Bachelor of Science - BS, Biomedical Engineering
ABOUT GEMMA SOBIERAJ
I am a biomedical engineer working in pharmaceutical manufacturing and validation, supporting complex projects across regulated healthcare environments. Since graduating from Rochester Institute of Technology in 2025, I’ve built hands-on experience in commissioning, qualification, validation, and technical problem solving across both medical technology and pharmaceutical settings.I am currently pursuing a Professional MBA at the University at Buffalo to strengthen my leadership and business skill set, complement my engineering background, and support long-term impact at the intersection of technology, healthcare, and operations.
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