Mississauga, Ontario, Canada
With over 20 years of combined experience in engineering and project management, I am a driven and versatile professional who leads and delivers complex capital and construction projects in the pharmaceutical industry. As a Manager of Capital Projects and Site Relations at Apotex Inc., I managed a $60M+ Capex budget along with our Senior Leadership Team and acted as a key relationship lead between capital and site leadership, ensuring alignment of goals and expectations. I have a strong background in design, fabrication, manufacturing, R&D, testing, and optimization, as well as technical writing and publishing. I hold a PhD in Mechanical Engineering and a Professional Engineer (PE) and a Scrum Fundamentals Certified (SFC) credentials. I am proficient in various technical software and tools. I am also fluent in English and Polish. I am passionate about applying my engineering skills and knowledge to improve the quality, efficiency, and safety of pharmaceutical products and processes.
Reporting to the EVP Global Strategy & Technical Operations, execute and support high value, complex & strategic capital projects across the Bimeda North America manufacturing site network including Cambridge (Canada), Minnesota (US), Texas (US) and California (US). Lead strategic capital projects through entire lifecycle, overseeing scope, budget, timelines, risk, and stakeholder communication, from initial planning to post-completion evaluation. Develop project charter and management plans, collaborate with cross-functional teams to define and manage project elements ensuring quality and risk mitigation, manage budgets, and act as the primary interface between the project and its stakeholders to achieve objectives. Prepare detailed capital project justification submissions for large-scale, multi-disciplinary projects, ensuring alignment with strategic business objectives.
New sales & capital projects, Contract Pharmaceutical Packaging, Production and Facilities Equipment, Construction Management, tech transfers/tooling, Lead cross-site, cross-functional teams to meet and exceed required business and regulatory standards, product development/testing, customer focus, ensure cGMP compliance, Part of Energy Team (Sustainability), Facility and Equipment Capital Projects, Pharmaceutical Construction SME
Manage $60M+ Capex budget, manufacturing equipment and construction projects Key Relationship Lead between Capital and Multi-Site Leadership
Establish and manage scope, resources, budget, schedule, construction and start-up of various Capital Projects and Leasehold Improvement Projects ensuring all work is performed in compliance with company Code of Conduct, Business Ethics, and related policies as well as legal, regulatory and safety requirements (cGMP, Ontario Building Code and MOL/MOE, etc.); Act as a Site Relationship Leader to partner directly with Site Engineering Directors to ensure seamless planning and execution of capital projects and assist in meeting corporate goals and objectives; Use mechanical, electrical and/or process systems expertise to lead and/or support the development and execution of FAT, commissioning and validation requirements with associated documentation; Lead the development and ongoing maintenance of corporate engineering design and construction standards; Support troubleshooting and problem resolution of facility systems and operational equipment
Developing optimum technical solutions to meet functional and regulatory requirements; Leading Capital and Change Projects by providing effective Project Management, which includes development of project requirements/ specifications and cross-functional teams as well as planning, project monitoring/tracking and Communication Management; Selecting and managing professional consultants, contractors and suppliers; Being responsible for the specification, procurement, installation, commissioning, qualification and hand-over of capital and change projects; Leading and supporting engineering compliance through internal audits, corrective and preventative actions (CAPAs) as well as production/facilities equipment maintenance activities
Project Management, Human Management, Technical Proposals, Sourcing, Budgeting, Resource Allocation, Scheduling, Contract Administration, Design, Conflict Resolution, Kickoff/Stage-Gate Meetings, Lean Manufacturing, Monitor/Manage Design/Test/Manufacturing Engineers/Technicians/Sales Staff, Product Development & Testing, Capital Projects, Equipment Installation & Commissioning, Technical Writing, Customer after sales support including training and warranty resolution, Execute strategic product application development plans, Provide technical support to business development segments, Provide quotations and interact with customers, Prepare/assist in the processing of acquired test data, Dealer/In-house Training, Funding Applications, QA/EHS Initiatives