We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs and troubleshooting. (MAMF Qualified)
• Required to operate and clean the process equipment as necessary.
• Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance.
• Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown.
• Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc.
• Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history.
• Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles.
• Operate, troubleshoot, and repair complex systems which may include Autoclaves, Glassware Washers, Single use mixers, HVAC, Isolators, filling line and inspection lines under minimal supervision in a highly regulated, cGMP environment.
• Interpret P&ID’s, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
• Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
• Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary.
• Assist in general facility upkeep and provides responsive customer support with emphasis on customer satisfaction.
• Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

• Time serviced MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
• Prior experience in a Good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential.
• Extensive hands-on experience of preventive/reactive maintenance.
• Understanding of mechanical/electrical/Instrumentation / pneumatic processes.
• Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects.