Biopharma Utilities Engineer: Commissioning & Handover Expert

Life Science Recruitment; Dublin; On-site; EUR 85,000 - 110,000; Full time

Job summary

Life Science Recruitment is assisting an award-winning Pharmaceutical organization in Dublin to recruit an engineer to support the delivery and readiness of utility systems for a new fill-finish facility. You will be involved from mechanical completion through handover to operations, ensuring CMMS readiness, calibration readiness, and robust PM programs.

You will collaborate with System Owners, Maintenance Supervisors and technicians, Quality, Validation and vendors to ensure safe GMP operation

Qualifications

• 3+ years engineering experience in biopharmaceutical or pharmaceutical project environments.
• 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.

Responsibilities

• Execute assigned project plan activities, identifying risks and dependencies and providing 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.

Skills

Maintenance readiness

Calibration

Commissioning

GMP knowledge

Tools

IBM Maximo

Veeva Vault QualityDocs

Trackwise

Job description

Life Science Recruitment is assisting an award-winning Pharmaceutical organization in Dublin to recruit an engineer to support the delivery and readiness of utility systems for a new fill-finish facility. You will be involved from mechanical completion through handover to operations, ensuring CMMS readiness, calibration readiness, and robust PM programs.

You will collaborate with System Owners, Maintenance Supervisors and technicians, Quality, Validation and vendors to ensure safe GMP operation