Maintenance Technician (E&I)

Summary:

Our client, a biopharmaceutical company based in Cork, is seeking a Maintenance Technician to join their Maintenance Operations team. The successful candidate will be responsible for executing plant-wide maintenance and utility activities in a GMP-compliant manner, covering areas including Upstream & Downstream Processing, Material Storage & Dispensing, Packaging, Drug Product Fill Finish, Clean & Plant Utility systems, WWTP, and HVAC.

Responsibilities:

• Proactively maintain process, utility and facility equipment in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the reliability agenda
• Perform maintenance and troubleshooting of equipment across the facility
• Interact with all process partners to continuously improve operations by recognising and correcting the causes of less-than-optimal equipment, facility and team performance
• Manage external vendor support to complete required services in a GMP-compliant manner
• Perform problem solving, including root cause analysis as required when equipment failures result in loss of production, substandard equipment performance, substantial repair costs and/or personnel safety incidents
• Ensure electrical, process and utility systems are maintained in a controlled state, ensuring compliance with all procedures, regulations and reliability initiatives
• Maintain a safe working environment by continuously promoting safety awareness, recognising and rectifying unsafe conditions, and performing thorough investigations when accidents occur
• Record all maintenance work performed on the site CMMS system
• Respond to critical utility alarms generated from the site’s automated alarm messenger system
• Maintain documentation, management and control systems in compliance with cGMP regulations and training instructions
• Complete and record calibration activities carried out on site and report any defects detected
• Contribute to the effective management of spares, consumables and contracts in a timely and cost-effective manner
• Utilise the permit to work system and other applicable safety systems to control engineering activities
• Participate in HAZOP reviews and design reviews as required

Qualifications & Experience:

• Relevant third-level qualification in Engineering or time-served apprenticeship
• Minimum 3 years’ experience working in a GMP regulated environment, preferably within biopharmaceuticals, pharmaceuticals or an equivalent regulated manufacturing industry
• Experience with drug product fill finishing and packaging activities is desirable
• Electrical background with the ability to maintain and troubleshoot a wide range of process and utility equipment
• Familiarity with CMMS systems and accurate record keeping within a regulated environment