Utilities Project Engineer: GMP Readiness On-Site

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

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,