• Technical leader for manufacturing equipment activities across the Dublin, Cambridge, Sandwich, & Southpointe offices in support of a diverse device technology portfolio.• Leader for fully integrated engineering solutions for all device programs deliverables through establishing internal team needs against external capabilities, Mylan Affiliates and Contact Manufacturing Organizations (CMO).• Responsible for sourcing key equipment manufacturer suppliers, establishing Confidentiality Disclosure Agreement (CDA), Master Services Agreement (MSA) and generation of Service of Works (SOW).• Lead and provide expertise in the development of equipment to meet product performance needs and product quality requirements, with continuous focus on capacity/scale up whilst managing cost requirements.• Provide support to all equipment product and process qualifications, through product realization to transfer to production.• Leader for the development of the end to end manufacturing strategy for New Product Introductions (NPI).• Responsible for development and implementation of the end to end supply of manufacturing process support material. Liaising with Supplier, Global Supply Chain (GSC), Shipping agents, Mylan Affiliates and CMOs. • Responsible for generation and approval of Capital Acquisition Requests (CAR), management of budgets both capital and operational, associated with external suppliers, ensuring proactive budget forecasting, and invoice management at qualification phases.• Responsible for establishing and maintaining Standard Operating Procedures (SOP) for the equipment validation lifecycle, including, User Requirement Specification (URS), Part 11 Assessment, System Categorization, etc. using industry best practices with Good Automated Manufacturing Practices (GAMP) methodology, and ensuring compliance to regulatory requirements. • Supporting audit activities both internal and external

• Operating in a project management role with primarily responsibility for delivery of multiple product transfers across various Value Streams. • Identifying project requirements from a validation and line requirement perspective, development of project plan, identification of key milestones, critical path items, and supporting functions.• Development of CAR submission for funding, justification of investment against project quantities accountability for management of budget and liaising with resources to ensure accurately tracking and reporting of forecast spend. • Management and directing of inter departmental teams, with focus on attaining product quality & maximizing timeline efficiencies through solid validation execution.• Manage the coordination of product release, based on regional needs, infantry, and contingency planning by supporting GSC, Planning, Variant Support and Regulatory teams ensuring alignment to go-live date and realignment as necessary due to business needs.• Responsible for management of process change control and conducting the appropriate risk assessments associated with the overall change proposed.• Evaluation and approval of changes that substantially impact the scope, budget, and project schedule. • Lead in resolving manufacturing issues arising from escalation of Operations team, through coordination of solutions by aligning the necessary support functions, action planning, task delegation, reporting and management of execution.

• Management of new orders with integration partners, introduction of process to stream line RFQ on new orders, and alleviate number of change requests during project lifecycle • Align with sister sites and partners to align requirements, prioritize projects and manage resources where unplanned schedule conflicts occur. • Maintain an overview of potential BP and assess partners ability to manage potential work load based on previous success, stability, and lessons learned • Liaise with Legal and department leads in draft and acceptance of Non Disclosure Agreement (NDA), Master Service Agreement (MSA), and, Service Level Agreement (SLA). • Coordinate and facilitate quarterly business reviews with the Senior Engineering Management and partners.

• Project leader for inspection, laser and robotic projects, bringing projects from concept phase to implementation phase, managing capital spend and providing timely and accurate updates on project activity. • Scoping of project requirements, identifying project objectives, developing cost analysis and submitting projects for approval. • Working with Supplier Quality to identify and introduce new vendors to the business, support audits and manage vendor set ups.• Supporting Procurement and Legal Departments in identifying suitable vendors, awarding projects and negotiation of Master Service Agreement (MSA) and Project Agreement (PA) contracts.• Liaise with vendors to scope, organize/manage project requirements and schedules. • Edit and publish documentation (URS, Validation Plans, Risk Assessments, Engineering Reports, etc.).• Supporting validations within Good Automation Manufacturing Practice (GAMP) guidelines • Preparation and execution of equipment protocols within such as Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation & Operational Qualification (IOQ), Process Verification (PV), etc. to a high level ensuring user requirements are satisfied and requirement traceability is achieved.• Supporting and implementing more robust processes across the Ringaskiddy facility. • Identifying opportunities to improve process throughput and improve process efficiency using Lean techniques.• Re-layout of production facility to introduce new systems and improving process flow, without disrupting production. • Technical leader for production release of laser marking systems.

• Integration of ASML lithography systems at semiconductor manufacturing facilities world-wide (WW).• Equipment owner during Factory Acceptance Tests (FAT) through Installation & Operational Qualification (IQ&OQ), up to and including site acceptance tests (SAT).• Ensured equipment was installed to meet customer specifications, with minimum downtime and within allocated budget.• Provided clear and concise communication daily between customers and inter-company departments regarding installation progress and issues.• Investigation and closure of Non-Conformances (NCRs) during integration.• Successfully completed integration of 3 XT and 5 NXT systems.• Applied a logical approach to troubleshooting using knowledge and skills of platforms, PCSs and fish bones.• Minimized downtime spent on future issues by having provided corrective actions and advised improvements on documentation.

• Upgraded customer production systems at WW locations with latest ASML modules.• Recalibration and revalidation of systems to achieve increased yield and throughput.• Successful completion of 5 NXT upgrades on time, within budget and ensured final product met customer specification.• Diagnosed and solved technical issues, and coordinated necessary specialised support.• Took an active role in team leadership to influence and support good team work.• Coached less experienced ASML colleagues.

• Preventive maintenance of 6 NXT and 8 XT systems at production and Research & Development (R&D) facilities.• Regularly provided clients with solutions to anticipated problems that would have affected production and qualification capabilities.• Assisted in the analysis of production data with MATLAB and SDT tools.

• Demonstrate the ability to solve basic mechanical problems and follow instructions.• Reporting serious machine issues to technicians and line managers.• Keeping machinery clean and sterile to meet food safety standards.• Quality control by ensuring all bottles are filled and labelled correctly.