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Work Background
Abbott Nutrition Supply Chain (ANSC)Principal Program Manager
Sep. 2023Cootehill, County Cavan, IrelandPrincipal Program Manager leading team of project and validation engineers delivering capital projects across full lifecycle in support of Abbott Nutrition Supply Chain.
Abbott Rapid Dx International LimitedSenior Validation Engineer
Jun. 2021 - Oct. 2023Galway, County Galway, IrelandSenior Validation Engineer providing key project support within the IDEM (Infectious Diseases Emerging Market) global QA Business Unit.
Key member within the lateral flow Project Team providing guidance and expertise to ensure successful project completion.
Responsible for creating bespoke validation documentation, complying with cGMP, regulatory requirements and site specific validation and quality related procedures.
Generation of validation documentation including DV, IQ, OQ, PQ protocols and validation reports, and assisting in the execution of protocols.
• Design, generate and execution of test plans and test protocols, managing and reporting findings and non-conformances.
• Maintaining consistency on validation/ qualification approach across projects, ensuring validation documentation is fully compliant with site specific policies/ procedures and regulations, good manufacturing practices and industry regulations.
• Supporting & encouraging others in the project team, with flexibility in the delivery of team results.
• Engaging with cross functional teams to deliver process validation objectives in compliance with regulations and procedures.
• Responsibility for delivery of project timelines.
• Ensure all project related issues and deviations are documented and approved.
Terumo Blood and Cell TechnologiesQA Validation Consultant - Projects (Contract)
Sep. 2020 - Jun. 2021Larne, Northern Ireland, United KingdomProject Validation Lead for extension to medical device facility and production operations for expansion to blood & cell technology manufacturing capacity.
• Presentation, as workstream owner, of project updates to Senior Management including reporting on Accomplishments/ Upcoming Activities/ Risk & Mitigation & Key Milestones, on a weekly basis
o Master Validation Plan for Utilities (Cooling Tower, Steam Boilers & Compressed Air Systems)
o Master Validation Plan for Water Systems (RO Water, WFI Distillation, Storage & Loop
o Software Validation documentation & review of test scripts for Historian Facilities & Utilities
control system
o Drafting of Test Method Validation documentation and test scriptsi ncluding URS,Risk
Assessments, Functional Design Specifications, Design Qualifications, IQ/OQ/PQ test
protocol /reports for utilities, water systems and production equipment for Gage R&R test requirements for Form Fill Seal machine
▪ Film-to-film, film-to-vial port peel testing ▪ Lateral Break Loose Force
▪ Spike Withdrawal Force test
• Responsible for scheduling and project resource allocations with responsibility for two associates.
• Responsible for ensuring compliance to local SOPs and industry standards.
AllerganSnr Project Engineer (Contract)
Aug. 2019 - Jul. 2020Westport, County Mayo, IrelandLead cross-functional project teams in the delivery of site capital plan and internal customer requirements.
• Project lead for pharma manufacturing Grade ‘A’ Clean rooms facility upgrade to Multi Dose Filling Lines Fan Filter Unit and controls system including procurement, construction management, FAT, commissioning, (IQ/OQ/PQ) validation and room recertifications in line with ISO14644 standard
• Project delivered on time and within budget
AbbottSnr Validation Engineer (Contract)
Mar. 2019 - Aug. 2019County Donegal, IrelandValidation Support for project to introduce new Freestyle Libre Sensor Kit Lines into production facilities at Abbott Donegal Plant.
Project, Facility, Utility, Equipment Qualification and Process Validation
Hollister IncorporatedSnr Project Engineer (Contract)
Apr. 2017 - Mar. 2019Lithuania• Design, Procurement & Project Management duties for a new 30,000m2 medical device manufacturing facility on a green field site in Lithuania.
• Site Due Diligence activities
• Management of Critical Design phase
• Procurement and tender process activities for Main Contractor Selection
• Review of Concept Design Submissions for Medical Device Facility Layout
• Technical Design reviews for Permitting & Procurement
• Detail Design reviews for Construction Works
• Liaising with Client and Contractors for Process Design flow works
• Design, commissioning & validation of Clean Room facilities (ISO Class 7)
• Commissioning & Qualification of Facilities Infrastructure and Equipment
Merit Medical Systems, Inc.Senior Validation Engineer, QA (Contract)
Oct. 2016 - Apr. 2017County Galway, IrelandResponsible for Design Assurance for product transfer for Arravasc’s PTA balloon catheters to Merit
Design Transfer documentation review including device manufacture, inspection & release documents
Development of Risk Management Documentation (QRMT, pQRMT)
Teleflex Medical OEMSnr Engineer, Design Assurance
Apr. 2016 - Oct. 2016AthloneResponsible for: Project Lead for successful Design History File Remediation in line with FDA Design Control Guidance for Medical Devices for product transfer of handheld, battery powered device & needle sets
AlkermesSenior Projects Engineer (Contract)
Sep. 2014 - Apr. 2016Athlone, IrelandProject lead with responsibility for delivery of engineering capital projects within highly regulated area of Pharmaceutical manufacturing including installation and commissioning of processing equipment critical to the production process, cleanroom upgrades, phased office upgrades and refurbishment program across the site.
MedtronicSnr Facilities Engineer
Jul. 2004 - Aug. 2014Galway• Design, Facilities & Project Management of Site Support Services for medical device facility encompassing 30,000sqm over 4 separate Buildings dispersed within a 30acre site serving a population of 2,400 employees and visitors.
• Successfully implemented ISO14001 certification for the Galway Site.
• Responsible for introduction of a series of energy management initiatives across the Medtronic site reducing energy consumption by 12% in FY2010.
• Lead for successful energy audit in FY2010Q2, resulting in Medtronic site receiving IS EN 16001 EN accreditation.
• Created the Site Energy Management Procedure & responsible for compilation of Annual Energy Management Report.
• Responsibility at Medtronic for life cycle forecasting & administration of annual Facilities budget
• Customer Innovation Centre: Execution of construction and fit-out phase for new multi-award winning 2,500sqm hospitality building in 2014 delivering a customer experience for clinical & administrative business partners. Capital Budget delivered under spend by 9.8% (Budget €11m).
• Extensive knowledge of quality systems, FDA and EU GMP regulations & guidelines: ISO 13485 and QSR/CFR Parts 820 & 210/211, 21 CFR Part 11 & GAMP in implementing working practices to conform with highly regulated area of Medical Devices.
• Specification, design and verification of Facilities, Utilities and Manufacturing Equipment.
• Development of User Requirement Specifications; Design Specifications, Traceability Matrix, Risk Assessments.
• Devised new DOP for Facility Validation and Re-qualification; procedure highlighted in a corporate audit and has been adopted throughout the organisation.
• Management & Performance of Software validation (to CFR Part 11) of Building Management System (Trend 963).
• Published various procedures including development of Facility Validation Master Plan, the cleaning procedure for Cleanrooms, Gowning Procedure etc.
Parthus-CevaFacilities Manager
Apr. 2001 - May. 2004Dublin
White Horse Facilities Management LimitedAssociate
Jan. 2000 - Apr. 2001
PML (Programme Management) LimitedFacilities Consultant
Jun. 1998 - Nov. 1999London
Cantor Fitzgerald InternationalFacilities Manager / Controller
Feb. 1997 - Jun. 1998London
Steensen Varming Mulcahy Partnership LtdFacilities Manager
Feb. 1993 - Feb. 1997
Air Care Systems LimitedInstallation Engineer
Jul. 1991 - Feb. 1993Berkhamsted, Hertfordshire
Delap and WallerTrainee Engineer
Sep. 1985 - Jun. 1987Derry
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