Expert Details

Expert in Safety Management in Industry and Construction

Expert ID: 722219 Ireland

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At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma irradiation facilities in Europe. This also involved development, testing and approval of a wide range of plastic materials. He was intimately involved in the startup of the major contract gamma sterilization facility in Ireland. He developed a novel (confidential) source characterization technique that greatly simplified this task as well as developing a simple product simulation system that facilitated accurate placing of dosimeters during multiple runs. He also managed the construction of a new automated EO sterilization facility with a capacity for three 12-pallet chambers. He also developed and implemented the validation protocols for this equipment.

Expert is a Graduate Member of the UK Institute of Packaging and has many years’ experience in the selection of materials, package design, and automatic packaging equipment for the disposable medical device industry, particularly in the area of high-speed form-fill-seal equipment. He currently lectures on pharmaceutical packaging design to pharmaceutical science students.

Expert has considerable experience in the use of cobalt-60 sterilization systems. He was responsible for the development and implementation of the first customer validation programs carried out on an MDS-Nordion facility in Ireland in 1995.

Having recently completed a Diploma in Occupational Health & Safety (with Distinction) and a Bachelor of Science Degree in OH&S (with 1st Class Honours), Expert is now using his over 30 years of manufacturing engineering experience to advise on construction safety. He is currently on contract to Ireland's largest construction company in the capacity of Safety Manager on a pharmaceutical manufacturing facility. The key responsibilities here relate to managing the safety related activities of external contractors, including risk assessments, development of control measures, and reviewing/approving method statements. Specific areas of application include: developing and delivering accident and injury reduction programs; advising on confined space safety; dealing with excavations, drainage and general ground works; eye protection against injury from the use of various processes including rotating, percussion, and explosive tools, hand tools, plant and specialized equipment and use of chemicals; administration of a permitting system for many activities including "working at heights"; and development and implementation of lockout/tagout procedures for electrical, mechanical, and chemical processes.

In addition to his on-the-job consulting work mentioned above, Expert advises on safety in off-the-job situations including on the topic of "home safety". He has also recently delivered safety lectures to schools, under the banner of "Play Safe-Stay Safe,” in relation to construction sites.


Expert currently provides a safety and environmental consultancy service to construction and manufacturing clients. Expert provides assistance with interpretation of regulatory requirements in relation to safety and environmental management systems.

Education

Year Degree Subject Institution
Year: 1975 Degree: Graduate Diploma Subject: Packaging Engineering Institution: UK Institute of Packaging
Year: 1966 Degree: Diploma Subject: Electrical /Telecomunucations Engineering Institution: College of Technology, Kevin St. Dublin
Year: 2004 Degree: B.Sc. Subject: Occupational Health & Safety Institution: Sligo IT, Sligo, Ireland
Year: 2005 Degree: Diploma Subject: Training & Further Education Institution: National Univ.of Ireland Maynooth

Work History

Years Employer Title Department Responsibilities
Years: 2004 to Present Employer: Undisclosed Title: Regional HSE Co-ordinator Department: Health , Safety & Environment Responsibilities: He is responsible for managing the implemenation and operation of HSE management systems at up to 20 Construction sites. These systems have ISO 14000 (Environmental) and OSHAS 18000 (Safety) accreditation.
Years: 2003 to Present Employer: Undisclosed Title: Safety & Environmental Advisor Department: Construction Safety Responsibilities: He is presently on a contract as the Site Safety Manager on an expansion to an existing pharmaceutical manufacturing facility. This responsibility covers all safety management aspects of external contractors, including civil, structural, architectural, mechanical, electrical, and instrumentation activities.
Years: 2001 to 2004 Employer: Sligo Institution of Technology Title: Part Time Lecturer Department: Engineering & Science Responsibilities: He lectured to both engineering and science students on a range of modular topics including: industrial automation, intellectual property management, and pharmaceutical packaging.
Years: 1979 to 2000 Employer: Abbott Laboratories Title: Manager Department: Technical/Engineering Responsibilities: Expert held various Technical/Managerial positions, including Manager of Packaging Development, Manager of Process Development, Manager of Product Development, Manager of Sterilization Technology, and Project Manager.
Years: 1976 to 1979 Employer: Becton Dickinson Title: Senior Development Engineer Department: Engineering Responsibilities: He was a Senior Development Engineer with special responsibility for Assembly Automation and Packaging Systems.
Years: 1970 to 1976 Employer: Becton Dickinson Title: Senior Quality Assurance Engineer Department: Quality Assurance Responsibilities: He was a Quality Assurance Engineer with special responsibility for Process Development including conversion to Gamma Sterilization.
Years: 1966 to 1970 Employer: Phillips Electrical & General Electric Title: QA Specialist Department: Quality Assurance Responsibilities: Expert had various QA Specialist responsibilities including Reliability Engineering and Process Analysis.

Government Experience

Years Agency Role Description
Years: 2000 to Present Agency: Irish Aviation Authority Role: Pilot Experience Examiner Description: He is responsible for review of pilot flight time and verification of compliance with experience requirements at a number of flight training locations.
Years: 2006 to Present Agency: Health and Safety Authority Role: Advisor Description: He examines government managed Apprentice Training Curricula for Safety content and makes recommendations in relation to safety practices and methodology.

International Experience

Years Country / Region Summary
Years: 2001 to 2001 Country / Region: USA Summary: Expert has advised a large medical device manufacturing firm in relation to the selection of a sterilization system and the implications for existing product materials.
Years: 1995 to 1995 Country / Region: Canada/Ottawa Summary: He was an invited speaker to an international gamma processing conference in Ottawa hosted by Nordion International--a major player in the field of gamma sterilization--on the subject of conversion to gamma sterilization.
Years: 1994 to 1994 Country / Region: Puerto Rico Summary: He was an invited speaker on the subject of CE Mark accreditation at a sterilization conference in San Juan, Puerto Rico in 1994.

Additional Experience

Training / Seminars
Expert has delivered several lectures in relation to ethylene oxide (EO) and gamma sterilization systems. These related to equipment design, validation, and materials. He has also been invited to speak on the topic of project management by the Institution of Engineers of Ireland. In addition, he has developed and implemented acceptable flight training and ground school programs to meet the requirements of the European Joint Aviation Requirements.
Expert has developed and delivered a range of safety training programs for the Irish Construction Industry Federation (CIF) and for Sligo Institute of Technology ( Dip. and Degree level).
Marketing Experience
Expert spent three years as a product development manager for venipuncture products for Abbott Laboratories.
Other Relevant Experience
He holds a current JAA flight instructor rating and has considerable experience in the delivery of ab initio flight instruction and ground training courses to fixed wing pilots.

Fields of Expertise

irradiation sterilization, medical device package testing, medical device sterility, medical device sterilization, medical device irradiation sterilization, gamma-ray sterilization, medical instrument sterilization, medical device packaging design, medical device packaging material, medical device packaging process, cobalt-60 sterilization, contractor safety, construction safety, construction safety management, contractor safety management, safety, safety code, safety engineering, safety management, occupational safety, building safety, A Workplace Accident and Injury Reduction Program, confined space safety, excavation safety, eye safety, fall protection, lock out tag procedure, agricultural safety, aircraft safety, asbestos safety, chemical process safety engineering, construction, construction accident, construction safety equipment, electric circuit safety, electrical safety, emergency management, environmental safety, excavation, Occupational Safety and Health Administration, plant safety, off-the-job safety, accident reduction, workplace design, flight instruction, workplace injury, quality assurance engineering, health safety, intellectual property management, accident causation, construction defect, consumer product ergonomics, Environmental Management System, construction industry, building technology, gas handling safety, plastic manufacturing, decontamination equipment, plastic medical device, stainless steel safety, building architecture, power supply safety, shrink wrapping, construction equipment, process-engineering safety, fire risk analysis, chemical processing system safety, plastic forming, electrical safety code, plastic component design, maintenance safety, systems safety engineering, excavation trench, plastic molding, machine safety, electrical fire, electrical accident, building inspection, disaster planning, accident analysis, fire prevention, construction project management, fault tree analysis, building insulation material, building construction, building (object), building design, process safety, plastic material, industrial safety, building component, process safety management, building-related disease, accident, toxic chemical safety code, radiation safety, product safety, polyvinyl chloride, polystyrene, polypropylene, polyethylene, plastics safety, noise level safety code, intrinsic safety, industrial gas safety, fire safety code, explosion safety, construction material, building science, building code, administrative control, accident investigation

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