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.

• 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.