Engineering design for the pharmaceutical, food, and chemical industries.Process assessment, improvement, and design - • Facility and HVAC expansion design and project management• Production and packaging (primary and secondary) line design, layouts, installation, commissioning, and qualification• Equipment troubleshooting• Remediation for Health Canada and FDA compliance• Facilities improvements (HVAC, utilities, process flow)• Technical drawing reviews and updates/corrections• HVAC design and commissioning, including dust collection• Equipment qualification and Pre-Start Health & Safety Reviews

Responsible for strategic and day-to-day management of two pharmaceutical contract packaging facilities (primary and secondary packaging of commercial and clinical trial materials).Responsibilities included:• Management of Production, Logistics, Mechanical, and Custodial Services; 6 direct reports and departments encompassing approximately 48 employees• Strategic planning in all aspect of operations, including creation of capital and operating budgets• Cost estimation and quotation of new jobs• Continuous improvement of efficiencies and processes• Mentoring and leading department managers (direct reports)

Responsible for managing supply contracts for multiple third-party contract manufacturers and packagersResponsibilities included:• Maintenance of product supply to more than 60 worldwide and North American Markets• Analysis of demand and supply data and application to continued improvement in key performance indicators• Creation, negotiation, review, and amendment of legal supply contracts with third-party manufacturers and packagers• Working with local and worldwide teams to ensure continuity of supply to all markets• Troubleshooting of supply and technical issues

Responsible for a team of 12 engineers (direct reports) and allocation of resources to production support and capital projects. Responsible for product introductions, OE improvement, compliance projects, new equipment and equipment modifications in Solid Dose Manufacturing and Packaging

Responsible for all product introduction, OE improvement, and compliance projects in Solid Dose Foils & Blisters Packaging

Managed Package Development Team (four direct reports) responsible for all package development, packaging components, new product introductions, and artwork/graphics; as manager, responsible for all projects, resource allocation, and employee review/development

Researched and coordinated new equipment installations for packaging and processing of bulk pharmaceuticals.• Evaluated modifications to processes, methods, equipment, and systems. Ensured regulatory compliance to corporate and federal specifications.• Acted as technical support advisor to Operations division for ongoing process improvements and project management.

Prepared, reviewed, and revised validation protocols and reports to ensure compliance with current SOPs, as well as regulatory and corporate policies.• Executed validation activities as outlined in the McNeil Master Validation Plan.• Evaluated modifications to processes, methods, equipment, and systems and determined if revalidation is required.• Co-ordinated new engineering project implementations in Operations (packaging and processing of liquids and solid dosage forms), and provided technical assistance to Operations mechanics and external contractors.

Trained pharmaceutical manufacturing, quality assurance, quality control, and research & development technicians in pharmaceutical sciences and good manufacturing practices; developed courses on statistics, team/interpersonal skills.• Assisted in the design and construction of a pharmaceutical pilot plant, as well as indeveloping documentation systems and a master validation plan.

Responsible for a group of 17 second year chemical engineering students in a course on problem solving and interpersonal skills.• Assessed the students’ progress by marking weekly reports and conducting self-evaluation interviews, and ran workshops on creativity in problem solving.• As a graduate student at the university, my work involved two major projects: the reorganization of endothelial cell cytoskeleton under flow conditions, and the adhesion of cancer cells to resting and stimulated endothelium under flow.