Fastnet The Talent Group
Facilities Engineer. The Facilities Engineer will report to the Associate Director of Engineering and will provide support to the Carlow site as the Technical SME for various GMP and non-GMP systems, ensuring compliance to all site and regulatory procedures at all times. They will ensure that all equipment is properly operated and maintained in line with Company standards and industry best practice. Role. * Supporting the implementation of Reliability Engineering programs. * Participating in energy surveys and implementation of energy projects. * Keeping up to date on industry best practices specifically within the utilities area; including regulatory requirements for clean utilities. * Act as the point of contact for new capital and expense projects in the facilities area. * Identify, troubleshoot, investigate and remedy process and equipment issues and incidents, using Lean Six Sigma tools as applicable. * Lead continuous improvement projects through the identification of CAPAs from system failure investigations and investigation reports. * Lead complex multifunctional root cause analysis of system, process and equipment failures including, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; oversee and implement subsequent corrective action, through the change management system. * Develop Company standard SOPs and implementation of equipment maintenance plans, thereby ensuring all equipment is properly operated and maintained. * Drive compliance in line with Global Policies, Procedures, Guidelines, and regulatory requirements. Execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. * Direct and/or lead investigations re: deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions; preparation and analysis of facilities metrics reports to trend for improved operational efficiencies. * Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections. * Recognize and investigate opportunities for financial savings and supports opportunities for financial savings by providing resources, expertise and project work; Participates in development of profit plan and budgets. Requirements. * A Bachelors Degree in an Engineering or other Technical discipline. * 3 years of related work experience in a GMP manufacturing environment or equivalent. * Experience of mechanical/electrical/pneumatic processes. * Experience of working in a highly regulated environment applying regulations and compliance in all tasks undertaken. * Lean Six Sigma Methodology experience desired. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.
113 days ago