GxP Maintenance & Transition Specialist

Leo Pharma GmbH; Ballerup; Remote; DKK 700,000 - 900,000; Full time

Job summary

LEO Pharma in Denmark is seeking a Maintenance Support Professional to help keep critical facilities and utilities reliable during a major factory transition. You will provide technical support for maintenance planning and execution, ensure compliance with GxP, and collaborate across functions to deliver smooth shutdowns and site readiness for the new production facility.

The role emphasizes hands-on troubleshooting, robust documentation in CMMS and QMS, and contribution to CAPAs and deviations

Qualifications

• Solid technical expertise in maintenance of utilities and production equipment.
• Experience in regulated environments with GxP and quality processes.
• Knowledge of CMMS systems such as PEMAC and quality systems such as Veeva Quality.
• Experience with deviation handling, root cause analysis, CAPAs.

Responsibilities

• Provide technical support for maintenance planning and development across utilities, installations, plants and equipment at Site Ballerup.
• Act as troubleshooter on ad hoc technical assignments, breakdowns and operational challenges.
• Ensure maintenance documentation is aligned with LEO Pharma policies and GxP requirements.
• Create, review and technically approve documents in QMS in collaboration with stakeholders.
• Support structured close-down of the old factory and transition to the new facility.

Skills

Troubleshooting

Cross-functional collaboration

Documentation discipline

Proactive mindset

Education

Engineering degree or equivalent

Tools

PEMAC CMMS

Veeva Quality

Job description

LEO Pharma in Denmark is seeking a Maintenance Support Professional to help keep critical facilities and utilities reliable during a major factory transition. You will provide technical support for maintenance planning and execution, ensure compliance with GxP, and collaborate across functions to deliver smooth shutdowns and site readiness for the new production facility.

The role emphasizes hands-on troubleshooting, robust documentation in CMMS and QMS, and contribution to CAPAs and deviations