Excellent opportunity for a Maintenance and Calibration Lead to join a Biologics Leader in the West of Ireland. The Maintenance and Calibration Lead reports to the Engineering Manager and collaborates with Quality, Operations, and Technical & Scientific Affairs. They manage facility and utility maintenance and calibration programs, ensuring compliance with GMP, EHS, and regulatory standards. They prioritize team tasks and oversee preventative maintenance, calibration, and re-validation.
Overview of your responsibilities:
* Assign and prioritize maintenance workloads to support production and equipment validation.
* Lead preventative/predictive maintenance programs and breakdown investigations.
* Manage the eMaint CMMS system, enhancing functionality and operations.
* Coordinate daily activities and projects with internal teams, contractors, and agencies.
* Act as an SME during regulatory inspections, ensuring GMP and regulatory compliance.
* Collaborate with managers to maintain process and utility equipment.
* Supervise all scheduled and on-demand calibrations.
* Develop and lead team training programs for competency and compliance.
* Manage SOP and OJT training to ensure timely completion.
* Adhere to site SOPs, EHS standards, and legal requirements.
* Maintain high standards for EHS programs, ensuring compliance by all staff and contractors.
Knowledge, Skills and Experience Required for the Role:
* Bachelor's degree or trade qualification in engineering.
* 5+ years in GMP manufacturing, with 3+ years in maintenance of chemical, HVAC/mechanical, pneumatic & hydraulic, electrical, control, and building management systems.
* Experience maintaining utilities, facilities, and production/process equipment.
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