Toronto, Ontario, Canada
I Support the development, scale-up, qualification, and continuous improvement of manufacturing processes for pharmaceutical solutions
-Executed IQ/OQ/PQ protocols for GMP equipment; developed and executed a qualification protocol for a new dry fogger system. -Authored and executed 8+ autoclave PQ validations, ensuring sterilization effectiveness and GMP compliance -Conducted temperature mapping studies using Kaye validator systems and Ellab. Tools & Systems -Used SAP PM for material posting, work orders, inventory adjustments, and calibration tracking. -Performed calibration of equipment: peristaltic pumps, incubators, pressure gauges, cold storage units, and more. Documentation & Quality Systems -Authored and updated SOPs in collaboration with QA and Technical Services (e.g., material prep, equipment sterilization, fogging, and viral material transfer) -Executed cleaning validation protocols (e.g., U-bend loops, harvest valves) in collaboration with QA and Technical Services. -Led deviation investigations in Veeva (e.g., EM excursions, OOT events) using 5 Whys and 6Ms; supported CAPA implementation. -Supported PDP runs for new Renogen vaccine formulation with Technical Services. Aseptic Operations & Manufacturing -Operated the lyophilizer (prep, tray loading, recipe execution, troubleshooting). -Performed aseptic cell culturing, infection, and inactivation for 3 viral vaccine production campaigns -Led CIP/SIP of fermenters and inactivation tanks; trained operators on the procedure. -Conducted bacterial-based vaccine production as a fully trained operator: inoculation, harvest, aseptic vial filling, and lyophilization. -Participated in media fills as filling/capping operator while maintaining aseptic compliance; also trained new operators on aseptic technique and fill/finish procedures.
•Assisted customers with billing inquires •Performed technical troubleshooting •Advertised and sold products