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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Utilities Engineer


Reference:AS35001 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Mechanical Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This person will support the delivery and operational readiness of utility systems for a new fill-finish facility, from mechanical completion through to handover to the operations team.

Duties:

  • Execute the assigned project plan activities, identifying risks and dependencies, and providing clear progress updates to the F&E Manager and stakeholders.
  • Establish CMMS readiness in IBM Maximo, including system locations, hierarchy, equipment and child assets, classifications, engineering work requests and asset-number set-up.
  • Execute commissioning and operational spare-parts readiness: assess vendor recommendations, develop draft approved spares lists, coordinate Z-number creation, validate budget and storage availability.
  • Define and implement instrument calibration readiness: obtain and classify instrument lists, complete criticality assessment, define calibration scope and strategy, support CCD (critical control device) set-up, and ensure calibration job plans, datasheets, work orders, initial calibrations and loop checks are complete.
  • Develop the preventative-maintenance programme by reviewing vendor and site standards, drafting and approving PMs/job plans, establishing maintenance structures and sequencing, and ensuring applicable job hazard analyses are identified, developed and effective.
  • Coordinate vendor and technician training readiness, including training proposals and agreeing course content.
  • Determine whether vendor SLAs or maintenance agreements are required and coordinate draft development, review and approval with the vendor and internal stakeholders.
  • Develop, review and track required equipment SOPs and operational documentation, ensuring deliverables support safe GMP operation and handover.
  • Be heavily involved in commissioning activities as systems come on line, working alongside the project commissioning team, vendors and operations. Support field walkdowns, issue resolution, documentation review, loop-check and initial-calibration readiness.
  • Work closely with System Owners, Maintenance Supervisors and Technicians, Capital Project Engineers, Quality, Validation, Stores, Finance and vendors to resolve issues and maintain delivery against key dates.
  • Manage change controls and support investigations, risk assessments and technical problem-solving in accordance with GMP, EHS and site procedures.
  • System Experience Desirable:
    • Clean utilities: WFI, clean steam, purified water, process air and nitrogen.
    • Other utilities: glycol, non-GMP HVAC, instrument air, service/chilled/potable water, LPHW and process waste.
    • Controlled-temperature units, including fridges and freezers, and associated qualified and non-qualified control systems.
Education and Experience:
  • Bachelor's degree in engineering or equivalent relevant engineering experience.
  • Typically 3+ years' engineering experience in a biopharmaceutical or pharmaceutical project environment; utilities, greenfield start-up or equipment lifecycle experience is strongly preferred.
  • Strong grounding in biotechnology or pharmaceutical manufacturing, including GMP/GDP, data integrity, EHS, change control, deviation/investigation processes and good documentation practice.
  • Demonstrable experience of maintenance readiness, asset management, calibration, commissioning support, qualification support or operational handover activities.
  • Strong, hands-on IBM Maximo experience, including locations, asset hierarchies, classifications, work orders, preventative-maintenance structures, job plans, calibration records and spare-parts data. Experience with Veeva Vault QualityDocs or equivalent document-management systems is desirable.
  • Experience of change control (Trackwise), GDP-compliant documentation, technical report writing and cross-functional project delivery.
  • Strong practical mechanical and troubleshooting capability, with the confidence to work alongside maintenance, commissioning and vendor teams on site in a new facility environment.
If interested in this posting please feel free to contact Avishek Singh at [email protected] for further information.