Summary:
Our client, a biopharmaceutical company located in Waterford, is seeking a Reliability Engineer. The ideal candidate will be essential in supporting equipment and maintenance reliability to ensure uptime and minimise risks in critical manufacturing operations. The incumbent will be identifying and addressing equipment reliability risks to enhance operational efficiency and continuity.
Responsibilities: Serve as a subject matter expert on equipment reliability, focusing on maximising uptime across manufacturing and essential utility systems. Identify, assess, and mitigate reliability risks through proactive maintenance strategies, including Reliability Centered Maintenance (RCM) and FMECA studies. Optimise and rationalise Preventive Maintenance (PM) procedures, ensuring maintenance operations are efficient and effective. Lead or support Continuous Improvement (CI) projects to improve equipment reliability and overall site performance. Coordinate and execute planned shutdowns, managing all aspects from preparation to communication and resource allocation. Conduct downtime analysis to identify improvement opportunities and implement corrective actions. Maintain a high level of competency in CMMS (e.g., PEMAC, Maximo, SAP PM) to monitor, analyse, and report on maintenance activities and asset performance. Oversee vendor and service-level agreements (SLA) management, ensuring high-quality service standards for equipment support. Ensure all maintenance activities comply with quality systems, including Change Management, CAPAs, and SOP updates. Adhere to cGMP standards, ensuring compliance in all aspects of equipment maintenance and reliability. Qualifications & Experience: Level 7 Engineering degree or Higher Certificate/Diploma in Engineering. Minimum 2 years of experience in a maintenance, reliability, or engineering support role within a biopharmaceutical, pharmaceutical, or medical device manufacturing environment. Strong understanding of asset care and equipment reliability, including familiarity with reliability-centered methodologies such as FMECA and criticality assessments. Experience in PM optimisation and rationalisation, with a focus on operational efficiency and continuous improvement. Proficiency in conducting downtime analysis and root cause analysis to drive improvements. Competence in CMMS software such as PEMAC, Maximo, or SAP PM. Knowledgeable in Quality Systems, especially in Change Management, Deviation management, and CAPA processes. Prior experience working in a cGMP-regulated environment.
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