Sterile Operations Technician

Role Description

Our client is a IDA supported start up company, now hiring for a skilled Maintenance Technician from the Sterile or Pharma / GMP regulated manufacturing sector.

The Sterile Maintenance Technician provides essential maintenance and technical support to manufacturing across the full range of sterile manufacturing equipment. The role involves developing preventative maintenance (PM) routines, completing PMs on time in addition to reacting to machine breakdown to support manufacturing performance. The role also plays a significant role in ensuring all equipment related documentation meets the cGMP standards expected.

Main Duties:

  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
  • Provides maintenance support as required to include process systems, filling equipment, preparation equipment and clean utilities. Can provide basic automation and instrumentation support and liaises with automation/instrumentation specialists when required.
  • Uses structured problem solving in the event of equipment failure and documents all equipment interventions as required by the maintenance system.
  • Prepare preventative maintenance (PM) routines with other technical colleagues to minimise the risk of machine failure or equipment related deviations.
  • Completes PM routines on time.
  • Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
  • Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
  • Participates in bi-annual media fill studies to maintain qualification status.
  • Is diligent in the completion and review of maintenance and related documentation required to meet GMP requirements of a sterile manufacturing site.
  • Participates in and can lead continuous improvement teams. Proposes improvement ideas.
  • Takes ownership of manufacturing equipment performance and builds relationships with key OEM support contacts.
  • Supports capital projects throughout equipment lifecycle and supports process development projects and associated validation activities.
  • Reports accurately on all equipment downtimes to build history of equipment performance.
  • Is always prepared to escalate any safety, quality or performance risk observed.


Education/Experience:

  • Familiar with pharmaceutical equipment and systems such as CIP/SIP, autoclaves, filling machines, isolators, clean utilities.
  • Strong technical, troubleshooting and problem solving skills.
  • Senior trade in a mechanical, electrical or related field or Degree/Diploma and/or technical certification.
  • Proficient in use of Microsoft Office and other computer applications i.e. CMMS.
  • Strong team player with good proactive approach & manner

For more information or to apply, call 01 254 2278 send your CV in confidence to peter.godwin@ cpl.ie

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