Client: Confidential Start/End Dates: February 2017 to PresentScope/Description: Involved from Basis of Design through to completion of Detailed Design of a High Containment facility for the manufacturing and sterile filling and lyophilisation of ADC (Antibody Drug Conjugate) products.Facility utilised single use technology for the manufacturing and purification of ADC drug product and nanogram containment isolation equipment for handling of highly potent materials. Facility also included the formulation and sterile filling and lyophilisation of the ADC products.Responsibilities: Responsible for BOD for clean utilities for facility which included purified water generation and distribution system, WFI generation and distribution system, Clean Steam Generation and distribution system, Compressed air and Nitrogen distribution. This included carrying out utility sizing calculations for the mentioned utilities. Responsible for the Detailed design / equipment specification, equipment package management and design approval for the following packages: • Conjugation Reactor and associated CIP skid. (BCD)• Single UF/DF (TFF) Skid (PALL – Allegro)• Single Use Chromatography unit (PALL – Allegro) • Negative Pressure Toxin dispensing isolator (Prosys)• Positive Pressure UDAF product handling isolator (Prosys)• Single Use Mixers (Merck)• Downflow Booths (ESCO)• Utility Panels Process responsible for the integration of (Bosch) sterile vial filling and Lyophilisation (IMA) line and managing design requirements with other disciplines.

Construction of a new manufacturing facility to fill and package a powder inhaler drug delivery device. Facility included two dispensing and blending suites, device powder filling lines and assembly and pack area.Responsibilities: Process Equipment Packages: Dispensing Isolator (Extract Technology), Dispensing Downflow Booth (Extract Technology).• Responsible for managing the design, installation and qualification of the above equipment• Responsible for the C&Q process of the equipment from writing user requirement specifications, chairing quality risk assessments, completing design qualification and carrying out FAT/SAT/IQOQ activities. Project Cost ReportingDealing closely with finance department to report actual commitments and expenditure on a monthly basis.Responsible for monitoring and reporting to corporate level; project commitments and future forecast spends and the cashflow for the $285M project.

Aerosol Manufacturing Line / FacilityResponsible for managing the construction and performing the qualification of a new ATEX facility and fill finish line for flammable aerosols for pharmaceuticals.• Lead Project Engineer for construction and qualification. • Responsible for monitoring schedule and reporting progress to key stakeholders.• Responsible for managing consultants and designers.• Participate in HAZOP reviews of the gas filling process.• Carry out change control as per company procedures.• Carry out system impact assessments in conjunction with subject matter experts in the company.• Responsible for the creation of qualification and validation documentation including user requirement specifications, quality risk assessments, design qualifications, commissioning documents, installation and qualification documents.• Train production personnel in the operation of the equipment or where necessary coordinate external training as required.Purified Water Generation System InstallationNew system was to be installed in the existing plantroom on 1st floor of main production building. Pure Steam Generation System InstallationProject involved the removal of the old purified water generation system to free up space for the new steam generator so that production would not be affected during qualification.Carton Former LineInstallation and qualification of Harro Höfliger top load carton forming line. CAPEX Reporting and MonitoringDepartment Safety Representative

Worked on design projects for a variety of leading pharmaceutical and food & beverage companies.Projects:Consultant (Coca-Cola Corporation Ireland) February ’08 – September ‘08Design of €240m Coca-Cola flavour manufacturing plant in Wexford's Drinagh Business Park Responsible for technically analysing and recommending suppliers for several equipment packages including pumps, heat exchangers, weigh scales, filters, UV units, flowplates and flame arresters for this state of the art manufacturing facility being built in Wexford. Involved in creating and updating process and instrumentation drawings, updating line and equipment lists. Involved in technical bid clarification meetings prior to placing orders for previously mentioned equipment packages. Responsible for calculations to a variety of equipment packages, including pump calculations and heat exchanger sizing calculations.Consultant (Vistakon Ireland – Phase 4B / 3GT IPA) January 2008 Worked on these projects editing line lists and performing P&ID checks. Was also involved in performing FluidFlow simulations and comparing results with manual pump sizing calculations.Consultant (Élan Corporation PLC, (Nanocrystal Manufacturing Facility))November 2007 to December 2007 Involved with the preliminary design of the facility. Involved in compiling the budgetary cost estimate and basis of design documents for client submittal.Consultant (Cordis Cashel Ltd., (Medical Device Manufacturing Facility))September 2007 to November 2007 Worked editing line lists and performing P&ID checks as well as line sizing calculations for gas distribution systems.

Worked in the EHS Department where I was involved with the creation of a pre-audit questionnaire for a corporate audit. Also responsible for the categorisation of environmentally critical pieces of equipment.