Project Utilities Engineer

PE Global (UK)

Dún Laoghaire

Hybrid

EUR 65,000 - 90,000

Full time

5 days ago
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Job summary

PE Global (UK) is recruiting for a Project Utilities Engineer for a leading multinational Biotech client in Dun Laoghaire. The role is a 12-month contract with a hybrid setup, three days on site per week.

You will drive project plans, CMMS readiness with IBM Maximo, commissioning support, calibration strategy and the development of the preventative-maintenance programme while collaborating with vendors and site teams.

Qualifications

  • Bachelor’s degree in engineering or equivalent relevant engineering experience.
  • Typically 3+ years’ engineering experience in GMP manufacturing or pharmaceutical project environment; utilities, greenfield start-up or equipment lifecycle experience preferred.
  • Strong GMP/GDP, data integrity, EHS, change control, deviation/investigation knowledge.
  • Experience with maintenance readiness, asset management, calibration, commissioning support or handover activities.
  • IBM Maximo experience with locations, asset hierarchies, classifications and PM structures; knowledge of Trackwise is a plus.

Responsibilities

  • Execute assigned project plan activities, identifying risks and dependencies with progress updates to the F&E Manager and stakeholders.
  • Establish CMMS readiness in IBM Maximo with assets, locations and hierarchies.
  • Coordinate commissioning and spare-parts readiness, budgets and storage feasibility.
  • Define calibration readiness and support calibration plans, data sheets and work orders.
  • Develop preventative-maintenance programmes including PMs and job plans.
  • Coordinate vendor and technician training readiness and course content.
  • Assess if vendor SLAs or maintenance agreements are required and draft reviews.

Skills

GMP knowledge
Project coordination
Problem solving
On-site collaboration

Education

Bachelor’s degree in engineering

Tools

IBM Maximo
Veeva Vault QDocs
Trackwise

Job description

PE Global is currently recruiting for a Project Utilities Engineer for a leading multi-national Biotech client based in Dun Laoghaire.

This is an initial 12-month contract position Hybrid, 3 days a week on site.

ROLE:
  • 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.
  • 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.
REQUIREMENTS:
  • Bachelor’s degree in engineering or equivalent relevant engineering experience.
  • Typically three or more years’ engineering experience in a GMP manufacturing 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.
  • Able to manage priorities, communicate clearly at all levels and deliver safely to demanding project timelines.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland

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