Maintenance & Calibration Lead

2 months ago


Sligo, Sligo, Ireland Cpl Full time

Maintenance & Calibration lead

Biotech

Permanent Sligo

Reporting to Engineering manager

The role is very much collaborative, requiring close business partnership with other functions in the organization in particular Quality, Operations, and Technical & Scientific Affairs . The Maintenance & calibration Lead is responsible for managing the facilities & utilities maintenance & calibration programs at the site, ensuring equipment is functioning at optimal levels while maintaining compliance to GMP, EHS, and regulatory requirements.

The Maintenance & Calibrations Lead will assign and prioritize tasks for the team and lead the preventative maintenance, calibration & re-validation programs onsite .

Duties


• Assign and prioritize workload for maintenance engineers as well as contingent workers to maintain equipment in validated state to support production schedule.


• Lead PM and PDM programs and breakdown investigations on site ensuring the highest level of reliability.


• Owner and SME for the eMaint CMMS system for the site and lead improvements to its functionality and operation


• Acting as subject matter expert and presenting related topics & details to regulatory inspectors during inspections. Ensuring that GMP and Regulatory requirements are complied with as evidenced by internal audits and inspections from Government Agencies


• Responsible for supervising and maintaining all scheduled and on demand calibrations for process & utility and site equipment.


• Developing and leading team competency and development through training programs as required.


• Lead breakdown analysis/investigations (root cause analysis, problem-solving tools) including deviation and corrective action plan management.


• Manage service level agreements and contracts with key suppliers and contractors.


• Own or provide engineering input to deviations, CAPAs and change controls.


• Manage the team on-call maintenance Rota and be available to provide on call cover for the site one week per month/as per business requirements.

Do you have the following?


• Bachelor's degree or similar trade qualification in an engineering discipline


• 5 years+ of industry experience in a GMP manufacturer with at least 3 years' experience in maintenance of chemical, HVAC/mechanical systems, pneumatic & hydraulic system, electrical power systems, control systems, building management systems.


• Experience in maintaining utilities, facilities & production/process equipment.


• Must have a strong technical aptitude.


• Good team player who enjoys collaborating with others to find effective solutions.


• Sense of ownership and accountability for own work.


• Experience working with CMMS (Computerized Maintenance Management Systems) – eMaint an advantage.

For more information reach out to


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