Milton, Ontario, Canada
I am currently based in Toronto and not available for relocation. I graduated with honors in Mechanical engineering at McMaster University with a focus on design and manufacturing. I then proceeded to complete my Master's degree in Engineering Product Design, also at McMaster. I work as an engineer in validation for pharmaceutical companies. I have worked at various pharmaceutical companies in and around the GTA, as well as in the United States and in Asia. I have extensive experience in thermal mapping, equipment qualification, aseptic processing, cleaning validation and development, and process validation. I have also worked as a project manager, automation manager, and process engineer for several years in the biotech industry. Previously I worked in the manufacturing industry, doing mechanical CAD designs and simulations for 80cc two-stroke engines and other products. I also executed time-workflow analyses and other LEAN initiatives. As a hobby, I design everyday objects and repair items with my 3D printer and have a history of volunteer work including being a Disaster Response Team Lead for the Canadian Red Cross.
Various roles throughout my time at Cheme include project manager, process engineer, automation manager, CQV lead, Training developer, and Marketing assistant. Project highlights to date: -CIP Optimization for 200+ circuits -Audit Resolution Task Force (alarm management, data integrity, validation gap assessments) -Spearheading thermal mapping and 360 warehouse mapping initiatives -Development and commissioning of an automated formulation line with cross-line ability -Design-build for in-line decontamination system (biohazardous material) -DeltaV commissioning for PK controller upgrade on fermentation line -DeltaV software validation for various upstream, downstream, MBWS equipment, including virtualization server -Feasibility for automation of tank cleaning
Consultation for C&Q activities in GMP environments -Acted as engineer in charge of Midstream equipment (centrifuge, microfiltration, ultrafiltration) -Acted as automation/CSV C&Q Lead for a new production facility -Executed FATs for microfiltration skids, isolators, inline dilution skids, fixed tanks -Executed software FATs for equipment controlled by DeltaV, including graphics testing, CM/EM verification and recipe testing -Lead for SIP PQ project in Asia, including technical troubleshooting and deviation investigations -Lead for Parts Washer cycle development and PQ while supporting SAT activities in Asia -Provide training (classroom and on -the-job) for SIP fundamentals and execution, and Parts Washer fundamentals and cycle development -CIP skid mixing study to provide recommendations to re-design team -Aseptic cleanroom qualification (dual-purpose for terminally sterilized products) -HVAC commissioning and qualification, control troubleshooting and differential pressure remediation -Residual Seal Force Tester qualification -Development of process and SOPs for compounding tank transfer and setup -Development of Impact Criticality Assessments and Failure Mode Effect Analysis for critical utility systems and HVAC units
We are a group of entrepreneurs who are developing board and card games. We develop all aspects of each game from the mechanics, storyline, illustration and packaging. My responsibilities include: Illustration of graphics for game cards and packaging Testing and Development of game mechanics Creative advisor