Utilities Project Engineer

DPS Group Global; Dún Laoghaire-Rathdown; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

DPS Group Global is seeking a Utilities Project Engineer to support the delivery and operational readiness of utility systems for a new fill-finish facility. The role requires on-site presence three days per week and close coordination with construction, commissioning, and maintenance teams to ensure GMP-compliant handover.

You will lead CMMS readiness in IBM Maximo, support calibration readiness, develop maintenance programmes, and manage change controls in line with GMP/EHS site procedures,

Qualifications

• Bachelor's degree in engineering or equivalent.
• Typically three or more years' engineering experience in GMP manufacturing or pharmaceutical project environment.
• 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.
• Experience with change control (Trackwise) and GDP-compliant documentation.

Responsibilities

• 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 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.

Skills

Project coordination

GMP knowledge

Stakeholder communication

Maintenance readiness

Education

Bachelor's degree in engineering

Tools

IBM Maximo

Veeva Vault QualityDocs

Job description

Role purpose

The Utilities Project Engineer reports to the F&E (Facilities & Engineering) Readiness Manager and supports the delivery and operational readiness of utility systems for a new fill-finish facility, from mechanical completion through to handover to the operations team.

Role purpose

The Utilities Project Engineer reports to the F&E (Facilities & Engineering) Readiness Manager and supports the delivery and operational readiness of utility systems for a new fill-finish facility, from mechanical completion through to handover to the operations team.

The role requires at least three days per week on site. Site presence is essential to coordinate with construction, commissioning, system owners, maintenance technicians, stores and vendors; verify equipment and documentation; and resolve execution issues at the point of work.

Key Responsibilities

• 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.

Experience And Qualifications

• 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.

Working arrangements

This is a hybrid project role with a requirement of at least three days per week on site. Additional site attendance and occasional vendor travel may be required during critical installation, commissioning, training and handover periods.