MICHAEL KUFORIJI

• Responsible for the Commissioning and Qualification activities for various equipment in a pharmaceutical manufacturing plant (Eli Lilly).

• Provide technical oversite for the commissioning, testing, and calibration of equipment including facilities, utilities, HVAC (air handling units, cooling towers, piping, etc.), and processing systems.

• Leads P&ID walk-downs, design/blue-print reviews, equipment model number verifications, equipment calibration compliance, installation and verification of certifications for all systems.

• Perform OV testing, Delta V operations and testing, monitoring and documenting results.

• Develop and execute protocols for systems and equipment, ensuring compliance with industry, regulatory, client, and cGMP standards.

• Installed, verified, and processed HEPA Filter Certifications.

• Utilize Kneat software to coordinate and communicate updates with clients, vendors, and project teams, establishing and maintaining project schedules and budgets.

• Project: Upstream Bioreactor Thermal Mapping CAPEX Project
• • Preparing Kaye Validator for performance of Bioreactor SIP PQ.
• • Installation/removal of Thermocouples and BIs for Large Scale Bioreactors, Transfer lines and skids.
• • Performing SIP runs using DeltaV and collecting data trends using Osisoft Pi software.
• • Working with cross functional teams in Quality, Engineering and QC to ensure delivery of tasks.
• • Upon completion of SIP PQ work scope, I performed PQ on some Incubators and Freezers.

• Preparing Design Qualification (DQ) Reports for Biogen’s Solothurn Site Validation Team.

• Supporting Client project timelines and requirements.

• Running Kneat documents such as CQV (IQ, OQ, PQ) protocols, reports and preparing document tracking metrics for the Validation Management.

• Preparing Spray Coverage Test Review reports for Biogen’s Swissmedic observations.