Fiona Boyle, PhD, MIEI

Experience

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  Medtronic

  May 2002 - Nov 2006

  • QA Associate Sterilization Engineer

    Sept 2005 - Nov 2006

  • QA Associate Microbiologist

    May 2002 - Aug 2005
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  NUI Galway

  Jan 2007 - Jan 2012

  Examination of antimicrobial resistance mechanisms in Gram negative Enterobacteriaceae from clinical samples and from veterinary samples. My PhD research focused specifically on analysing the genetic basis for antimicrobial resistance in microorganisms isolated from gut flora from clinical specimens from Africa and Ireland and veterinary specimen’s from Ireland. Further to this, I investigated a variety of antimicrobial resistance mechanisms in additional serovars of Salmonella, in E. coli, Pseudomonas species, Klebsiella species and Serratia species. Show less During this project I investigated the levels of antimicrobial residues and antimicrobial resistant bacteria in effluent from hospitals, pharmaceutical plants and intensive farming units (potential sources of antimicrobial residues and/or resistant bacteria). I assessed the relationship between antimicrobial residues and antimicrobial resistant bacteria in untreated water and proximity of the water source to the potential sources of antimicrobial residues and antimicrobial resistant bacteria outlined above. Lastly the final deliverable of the project was to assess the impact of secondary wastewater treatment on the levels of antimicrobial residues and antimicrobial-resistant bacteria in water. Investigated the presence of antimicrobial residues (other than chlorine) and antimicrobial resistant bacteria in water supplies. Show less

  • Doctoral Researcher

    Jan 2007 - Jan 2012

  • EPA Research Assistant

    Jan 2007 - Dec 2007
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  Medtronic

  Aug 2011 - Jun 2012

  QA Sterilization/ Biocompatibility Engineer

  I have extensive experience (>6 years) in QA Microbiology and sterilization validation with a regulated multinational company. I have been involved in internal audits, external audits, FDA, BSI, IMB and TGA audits. I have been responsible for the QA Microbiology testing, analysis and reporting for at Medtronic. I have validated cleanrooms and carried out annual clean room validations, I have been responsible for document generation and maintenance (SOPs, CVSOPs, PQs and DOPs), corrective action generation and closure upon implementation of effective preventative action. I was a SME (Subject Matter Expert) for Microbiology in Medtronic. I have test method validation experience and calibration of laboratory equipment experience. I was involved with management on a daily basis to rectify ongoing microbiological and sterilization issues.I was responsible for assessment, validation and routine processing of products for E-Beam, Ethylene Oxide, and Gamma sterilization. I have extensive experience in sterility testing, and Biocompatibility testing. Show less

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  BVP (Ballinskelligs Veterinary Products)

  Jun 2012 - Oct 2013

  Quality Manager

  Review and approval of all GMP documents and ensure that documents are appropriately stored and retained. Deviation review, approval and management.Change control, review, approval and management.To coordinate and approve with QP all equipment, utility, process cleaning and analytical method validation protocols and programmes. To make decisions based on the execution of the validation programmes and analytical data derived.To liase with the QP and ensure that Quality Risk Management principles and ensure that audits are conducted abd appropriate actions are taken.To approve and monitor material suppliers, contract laboratories and other out sourced activities by technical agreement, auditing or testing of samples as required.Non-conformance review and follow up of corrective and preventative actions.Ensure ongoing training on changing requirements of GMP and on the job training is provided to all personnel.To ensure that the manufacturing environment is monitored and controlled in conjunction with the Production manager including HVAC systems, plant hygiene, process controls, storgae conditions etc.To compile and trend data related to all QA systems (complaints, deviations etc.) and products (rejects, PQR etc.) and present this data to the Senior Management Group to ensure that appropriate corrective and preventative actions are taken and resources are made available.To assist the QP, in constant striving for continuous improvement on the quality of the product and processes at BVP.Liase with members of the IMB and VMD and other regulatory authorities as required.To approve specifications, sampling instructions, inspection methods, test methods, validation protocols and other quality control procedures for both chemical and microbiology testing.To ensure raw materials, packaging material, intermediates and finished products are appropriately sampled and tested for chemical and microbial attributes and to approve or reject these materials as appropriate. Show less

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  Stryker

  Nov 2013 - Mar 2016

  QE II Sterilisation
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  DePuy Synthes

  Mar 2016 - Jun 2018

  Staff Scientist, Sterility Assurance
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  Munster Technological University

  Jun 2018 - Sept 2018

  Quality Management AL

  Preparing all lecture and course material, along with setting and evaluation of continuous assessments and final exams (Quality Standards and Auditing). Material was delivered to personnel employed in the MedTech. Pharmaceutical, Food, Electronics and Automotive sectors.

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  AgriTech Centre of Excellence (ACE)

  Nov 2018 - Oct 2020

  Manager, Agritech Centre of Excellence (ACE)

  ACE is a collaboration between Dairymaster, McHale Engineering, Abbey Machinery, Kerry CountyCouncil and IT Tralee to develop an AgriTech Centre of Excellence (ACE) that will be based in ITTralee and will support an exponential change in the industry. The centre will identify, research,share and implement best practice in innovation, processes and systems, people skills, companycapability and internationalisation to deliver sustainable market growth.The project is a game changer in the AgriTech sector and offers a new and exciting approach tosectoral learning and development, through e-learning and virtual reality. ACE is the first of its kindin Ireland & indeed Europe and is therefore, in its very nature, innovative. ACE will enhance thecapabilities of Ireland’s AgriTech businesses/companies and expand their reach and global ambition,thereby positioning Ireland at the forefront of the international AgriTech industry. Show less

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  Stryker

  Oct 2020 - Feb 2021

  Principal Microbiologist
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  Munster Technological University

  Feb 2021 - now

  Head of Department-REEdI
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  Lero

  Jul 2024 - now

  Funded Investigator