We are seeking a skilled Mechanical Specialist to join our team in Carlow.
About the Role:
This is an exciting opportunity for those seeking to work with cutting-edge equipment and technology. The successful candidate will be responsible for providing technical support to Production, ensuring effective maintenance, installation, and modification of machine and equipment.
The ideal candidate will have a Time-served MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline. Prior experience in a Good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential.
Key Responsibilities:
* Provide technical support to Production, ensuring effective maintenance, installation, and modification of machine and equipment.
* Operate and clean process equipment as necessary, maintaining a high level of cleanliness and organization.
* Ensure ongoing preventative maintenance, equipment troubleshooting, and repairs to guarantee continuous, reliable, and repeatable operation of all equipment, driving Total Productive Maintenance.
* Manage equipment shutdown scheduling, allocating resources efficiently to minimize downtime.
* 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, to ensure accurate records and repair history.
* Operate and monitor production support equipment using MES/DCS and PLC based systems, optimizing equipment uptime and target outputs while implementing continuous process improvements using Lean Principles.
* Perform complex system operations, troubleshooting, and repairs under minimal supervision in a highly regulated, cGMP environment, including Autoclaves, Glassware Washers, Single use mixers, HVAC, Isolators, filling line, and inspection lines.
* Interpret P&ID's, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
* Lead and participate in continuous improvement initiatives, including repairs, upgrades, preventative maintenance, and system failure investigations, contributing to Kaizen events as appropriate.
* Conduct root cause analysis of system failures and substandard equipment performance, resolving issues through standard tools and methods, and implementing corrective action through the change management system.
* Supply information and technical data for securing spare parts and equipment asset entry into the CMMS, liaising directly with vendors as necessary.
* Assist in general facility upkeep and provide responsive customer support, emphasizing customer satisfaction.
* Participate effectively in writing/revising/rolling out accurate operational procedures, training materials, and maintenance procedures for various IPT systems, ensuring compliance with applicable guidelines.
* Comply with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good manufacturing Practices (cGMP) in day-to-day activities and job functions.
* Collaborate to drive a safe and compliant culture in Carlow.
Requirements:
To succeed in this role, you will need:
* A Time-served MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline.
* 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, with excellent communication skills on technical subjects.