Roger Lobo, B.Eng, PMP

Experience

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  GlaxoSmithKline

  Jun 2006 - Aug 2006

  Engineering Assistant

  -Worked with Ointments, Liquids and Topical Line 1-Recorded data during start up and shut down-Worked on a statistical analysis to develop presentations during plant shut down

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  Canada Border Services Agency | Agence des services frontaliers du Canada

  May 2007 - Aug 2007

  Border Services Office (Student)

  -Trained in RCMP Controlled Defensive Tactics-Completed various inspections of goods-Familiar with Customs Act of Canada

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  Sanofi Pasteur

  May 2008 - Aug 2009

  Health Safety and Environment Systems Technician

  -Participated and developed in various internal and external audits-Completed on fire protection and glass safety projects-Completed environmental projects such water metering, waste disposal, chemical waste disposal, refrigerant cataloging, etc..-Responsible for HSE TrackWise and PASS program-Trained over 300 employees on 7 different courses.

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  Sage Engineering Services Ltd

  Jun 2010 - Jun 2011

  Consultant Engineer

  -Project coordination and implementation role-Inspection of equipment and facilities to determine risk factors-Compiling and investigation of cleaning validation rubics for Q6 initiative-Assessing line clearance initiative tasks

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  Formula North Inc.

  Jan 2011 - Jun 2017

  Business Event Lead & Sponsorship Director

  -Lead Fundraising Event Committee for non-profit organization.-Participate in Event Organization Committee.-Work with students and judges on business case studies and evaluations.-Lead on-track events on main event days with volunteers and committee members.-Responsible for safety and on-grounds communication at event.-Working to promote and organize Formula North Annual Event in Barrie.-Coordinating and obtaining sponsorship for non-profit event to bring higher level of education to Ontario. Show less

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  SNC-Lavalin

  Jul 2011 - May 2013

  Validation Specialist (Consultant)

  •Registered as a Nuclear Energy Worker under the Canadian Nuclear Safety Commission (CNSC). •Align CPDC new facility and equipment to meet Health Canada regulations and comply with cGMP practices to obtain license for drug manufacturing.•Developed gap assessments and summary reports for all commissioning and qualification activities to ensure that all critical validation activities is complete prior to Health Canada audit.•Generated and executed protocols for multiple Heating, Ventilation and Air Conditioning (HVAC) Systems pertaining to GMP and non-GMP areas.•Worked with design engineers to develop testing protocols for Building Automation Systems (BAS).-Executed and coordinate commissioning activities such as Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for process systems.-Executed and coordinated installation, operational and performance qualification activities for process systems.-Initiated and executed Commissioning and Qualification activities for mechanical systems.-Performed and coordinated testing for Validation activities.-Participate in on-site design and quality inspections for various process systems and facility systems based on schematic drawings and P&ID verificiation. Show less

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  GlaxoSmithKline

  May 2013 - Dec 2013

  Business Support Engineer

  -Coordinate equipment validation remediation activities.-Generate and execute equipment validation protocols.-Generate quality and safety critical documentation for engineering process in GMP environment.

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  Apollo Health and Beauty Care

  Mar 2014 - Jul 2014

  Manufacturing Engineer

  -Experienced in project management of capital projects including project controls, scheduling and engineering change control.-Implement process modifications and re-designs.-Initiate and review vendor quotes and bids, budget and expenditures.-Participate in line trials and commissioning.-Procure equipment for manufacturing and capital projects.

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  Apotex Inc.

  Jul 2014 - May 2024

  - Managed the onboarding of Contract Manufacturers Organizations (CMOs) for serialization and supply chain activities for new product launches and technical transfers in the United States, Canadian and GCC markets.- Led key projects for Apotex Indianapolis Distribution Centre such as a new validated cold chain shipping process, and Global Supply Chain security incidents process.- Led several workshops with multiple departments to process map several critical global initiatives such as partial case management reduction and quality initiatives such as FDA Form 3911 – Drug Notifications Show less • Managed several capital expenditure (CAPEX) projects for Production Equipment- Wash-In-Place Skid, Serialization (Optel) of Packaging Lines, Solvent-Rated Fluid Bed and Solvent-Rated Coating Pan including HVAC and BAS integration from user department.• Managed new product launch and product specific technical transfer projects that consisted of multi-disciplinary stakeholders that included scientists, engineers, maintenance & technicians.• Served as a subject matter expert (SME) for various solid-dose pharmaceutical manufacturing equipment such as Granulators, Coating Pans, Fluid Beds, Flakers, Packaging Lines including Serialization and Extruders.• Provided technical, analytical and troubleshooting support for incident and deviation investigations related to production equipment, maintenance & engineering, building systems and packaging track-and-trace systems.• Managed and implemented various continuous improvement projects for process optimization and CAPA initiatives with multi-site and departmental teams.• Managed commissioning and qualification (C&Q) activities for Production and Packaging departments for small to large scale equipment including serialization upgrades, Granulators, Fluid Beds, Coating Pans, Extruders, Packaging Lines (Serialization) and HVAC systems.• Led compliance and operational excellence initiatives for quality audit preparation and lean manufacturing (Project Transcend) for various site-specific initiatives.• Recruited, coached and provided mentorship to coops and junior engineers by providing regular one-on-ones and managing their project workload. Show less

  • Program Manager, Logistics Systems & Training

    Dec 2023 - May 2024

  • Project Manager, Global Secure Supply Chain

    Mar 2022 - Jan 2024

  • Project Leader

    Jul 2014 - Mar 2022
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  AstraZeneca

  May 2024 - now

  Process Design & Optimization Manager

  - Managed key projects for Ethics Privacy Enablement & Innovation Centre for AstraZeneca Global specific to global and country specific regulations for privacy, compliance and human rights.- Led several workshops to develop new processes for technology upgrades for AstraZeneca Privacy Office.- Led overseas workshops for Compliance Risk & Reporting specific to regulatory and financial sector for the global organization.- Liase with internal stakeholders such as IT and external stakeholders such consulting firms as technical project manager to develop new solution platforms.- Develop a new change management and vendor management program for global compliance team. Show less