Olivier Vrain has a BSc in Chemistry and Pharmaceutical Science. Olivier has been part of STERIS AST Organisation since 2006. Prior to this, Olivier worked for diverse Healthcare companies in France and in Ireland.
He was involved with the Tullamore, Ireland E-Beam project from the onset and subsequently took on the role of the E-Beam Technical Engineer before to be promoted to the Radiation Technical Manager, UK & Ireland, position that he occupied until September 2016.
Olivier current position is Radiation Plant Manager for the STERIS AST Tullamore site in which he has the Operations responsibility for two electron beam irradiators and is an active member of the project team responsible for the X-Ray installation.
Olivier is an active member of the ASTM E61 on Dosimetry Committee and the Panel on Gamma & Electron Irradiation.
Mary Rijksen (B. Sc. Sci icrobiology, MSc. Biotechnology (NUIG) is an experienced Operations, Sterilization and Quality professional with circa 20 years’ experience directly in the Sterilization sector. Prior to this, Mary worked in the MedTech and Biotechnology sectors both in Ireland and The Netherlands. Ireland Operations Director since Jan 2021, Mary is currently responsible for multiple Sterilization facilities in Ireland covering various business segments including Ethylene Oxide (EO), Electron beam, Gamma and soon to be Xray. Before transitioning to Operations, Mary had Quality Operations, Regulatory and Compliance responsibilities at over 25 sites in 11 countries in EMEA. Mary is an adaptable and innovative leader with experience of managing cross functional teams in a matrix organisation, delivering for our CustomersShow more
Richard has over 25 years’ experience in sterilization of medical devices, of which 18 years were in various quality, operations and EO technical roles at leading global contract sterilization provider, STERIS. In 2022 Richard moved back into the medical device manufacturing arena as International Sterility Assurance Program Director for Medline Industries, providing support to their extensive sterilization activities in Europe and Asia. Richard has also been actively involved in ISO TC198 WG1 since 2006 and was project leader for the development of ISO/TS 21387 – Guidance on Parametric Release for EO processing, published in 2020. In Dec 2022 he was appointed convenor of WG1 and is currently leading the revision of ISO 11135, which is targeted for publication in July 2024.Show more
Gerry is Senior Principal Quality Engineer in the Sterility Assurance team at the Galway Parkmore Medtronic facility. Gerry has over 25 years of industry experience in the pharmaceutical and medical device industries. Gerry Has experience with EO , E-Beam , Gamma , Moist Heat , Dry Heat and Liquid Chemical sterilization modalities as well as Microbiology Lab management . Gerry received his B.A. degree in Microbiology from the University College Galway. He is a Certified Industrial Sterilization Specialist to the AAMI Credentials Institute and holds accreditation for CISS-Ethylene Oxide.Show more
Niall has over 20 years working in the medical device sector.
He has worked in microbiology, sterilization, biocompatibility, quality, and regulatory spaces.
He has just started in his current role with integer last week as their Senior Director, Global Regulatory, Design Assurance & Clinical Affairs.
Prior to that Niall worked for Phillips-Medisize, Jabil Healthcare, Boston Scientific, MedNova and Sanofi, always in the quality/microbiology space.
He has been involved in the to end sterility course working with the industrial partners, himself and Susan McMonagle were the industry leads for the quality, regulatory and biocompatibility module. He is also involved in the cleanrooms module.
A graduate of University College Cork, David received a doctoral degree for Microbiology in 2000. David has subsequently held Research & Development positions of increasing responsibility at the University of Minnesota (post-doctoral associate), 3M Healthcare (Microbiology Specialist) and Alimentary Health (R&D Director) before accepting the role of Microbiology Team Leader at DePuy Synthes Ireland in 2012. In March 2023, David assumed the position of Senior Director, Microbiological Quality and Sterility Assurance for J&J MedTech, where He directs the Microbioloigcal Quality and Sterility Assurance programs for Ethicon Wound Closure and Biosurgery, Ethicon EndoSurgery, Ethicon Robotics and Diagnostics and the Cardiovascular Speciality Solutions businesses of J&J MedTech (e.g., BioSense Webster, Cerenovus, Acclarant, AbioMed, Mentor, Sterilmed)Show more
Margaret O’ Halloran is a Principal Scientist of Microbiological Quality and Sterility Assurance at Johnson & Johnson Vision, supporting all Vision Care and Surgical Vision manufacturing sites in the EU. In conjunction with J&J, she has lectured on the UCC Biopharmaceutical & MD Microbiology undergraduate course, and is member the J&J Sterilization Council which is an Enterprise function .Prior to joining J&J , she has held senior positions in various multinational MedTech companies with responsibilities for sterilization in EMEA, US and other global locations.. Margaret is the current Vice Chair of the IMA Sterility Assurance forum, and is an active member of multiple ISO working groups for sterility assurance. She is an advocate for innovation and development of the sector and has been the industry lead for development of the Postgraduate programme in End-to-End Sterility Assurance in association with Skillnet and ATU which launched in 2023.
Margaret has a background in the study of Science, Technology & Innovation, Operations Engineering , at NUIG, UCC and UL, and holds a MSc in Medical Device Regulatory Technology from NUI Galway and Sligo IT.
I have worked with the IMS since December 2022 and prior to that worked with BioPharmaChem Skillnet for 7+ years. Previously worked in Project Management & Claims Management in the Insurance Industry.Show more