Paul McNicholas

Validation Specialist at Pharmaceutical Equipment Validation (PEV) LTD
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Contact Information
us****@****om
(386) 825-5501
Location
United Kingdom, UK

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Experience

    • Validation Specialist
      • Nov 2014 - Present

      Work primarily in GMP Sterilisation Validation for the Pharmaceutical, Biotech and Medical Device industries. My role is to participate in validation, temperature mapping, and calibration activities of sterilization equipment and/or the sterilization of equipment. I measure instrument or software performance to determine if systems are performing as described. My goals are to achieve high quality products on a consistent basis. I generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures). I analyze the results of testing and determine their acceptability against predetermined criteria. I also write protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated - doing what it's supposed to do. I analyze the results of testing and determine their acceptability against predetermined criteria. I adhere to strict documentation, reviews and approvals. I also investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements. Show less

    • Validation Specialist
      • 2014 - Present

  • EMCOR Group, Inc.
    • Salisbury, United Kingdom
    • Senior Instrumentation Technician
      • Jul 2011 - Nov 2014

      Joined Emcor Group as Senior Instrumentation Technician based at the Public Health England (PHE) Porton Down site. In this role, I performed scheduled maintenance calibrations and responded to breakdowns across two sites as well as project work upgrading and amending current installations. This entails liaising with equipment owners, primarily in cleanroom areas, on equipment from process vessels and centrifuges to water utilities and air quality systems. I was also involved in the assessment of calibration details and ensuring that the software configuration of all GAMP accredited equipment is up-to-date, properly documented and archived. Show less

  • Brunel Metrology Services Limited
    • Bristol, United Kingdom
    • Senior Calibration Technician
      • Jan 2011 - Jun 2011

      Joined Brunel Metrology as a lab-based Calibration Engineer. Brunel Metrology provides calibration and repair services on a wide range of equipment to a wide range of industry sectors. These include micrometers; slip and plug gauges; flow, temperature, and pressure meters; oscilloscopes; electrical meters; etc. As the only electrically-biased engineer in the lab, I was heavily relied upon to test and repair the majority of the electrical and electro-mechanical equipment. Joined Brunel Metrology as a lab-based Calibration Engineer. Brunel Metrology provides calibration and repair services on a wide range of equipment to a wide range of industry sectors. These include micrometers; slip and plug gauges; flow, temperature, and pressure meters; oscilloscopes; electrical meters; etc. As the only electrically-biased engineer in the lab, I was heavily relied upon to test and repair the majority of the electrical and electro-mechanical equipment.

    • Ireland
    • Facilities Services
    • 300 - 400 Employee
    • Automation Technician
      • Mar 2007 - Jan 2011

      Promoted within Lotus Automation and continued to be based at the Wyeth Grange Castle bio-pharmaceutical plant. As an Automation Technician in the utilities department, my main duties were the daily upkeep and the long-term improvement of utilities equipment. I also worked on project works in association with ICV teams in fault finding and commissioning so as to allow for easy hand over of equipment. The types of equipment I worked on were mainly wet utilities and HVAC systems. These include WFI, RO, CIP, skids and tanks, compressed air, HVAC units, LPHW, Steam and other ancillary units. This role also involved travel to the USA on project work. Show less

    • Instrumentation Technician
      • Jan 2004 - Mar 2007

      Joined Lotus Automation at the Wyeth (Pfizer) Grange Castle bio-pharmaceutical plant. I started as a QBMS Commissioning Technician and subsequently as a Instrumentation Technician. My responsibilities were to plan, implement and supervise technicians on the timely completion of scheduled and breakdown calibrations, including the replacement and repair of instruments, in the utilities and process areas. Instruments included pressure, flow, temperature, ph, conductivity, humidity etc. to cGMP procedures under IMB and FDA standards. Show less

    • Instrumentation Technician
      • 2004 - 2011

  • Calibration Specialists Ltd
    • Castletroy, Limerick, Ireland
    • Calibration Technician
      • 2001 - 2004

      I worked as a field and lab-based calibration technician in the Electronic, Aeronautical and Pharmaceutical fields. These areas consisted of working under the FAA, INAB (UKAS equivalent), ISO, IMB and FDA among others. I worked onsite in the field for almost two years under my own supervision liaising with customers in companies such as 3Com, Xerox, IBM, Flextronics, Pall, Lucant, EMC and Kostal to name a few. The work comprised of mainly high-end electronic equipment to basic mechanical equipment, including spectrum analyzers, curve tracers, signal generators etc. to power supplies, DMMs and mechanical equipment such as vernier calipers and micrometers. My final year was spent as a predominantly lab-based technician in Dublin Airport working on equipment used for the overhaul and maintenance of airplanes in FLS. Show less

  • Tellabs
    • Shannon, Co Clare, Ireland
    • SMT Technician
      • 2000 - 2001

      Employed by Tellabs to design, develop, deploy and support solutions for telecom service providers. My duties in this position were to fault find to board level at ICT and Functional test level Employed by Tellabs to design, develop, deploy and support solutions for telecom service providers. My duties in this position were to fault find to board level at ICT and Functional test level

Education

  • Limerick Institute of Technology
    Bachelor's Degree, Automation and Control
    1997 - 2000

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