The primary responsibility of the Mechanical Engineer is engineering support for manufacturing operations and process equipment within the Cleanroom environment in the site. This role will support the implementation of the Maintenance Asset Management Strategy for the Project to ensure the correct maintenance program is applies to all process assets on site. Provide Technical support on reliability improvement elements, as directed by the site’s Reliability Excellence (Rx) Program, including the management of the production Predictive Maintenance system. Reports to Associate Director of Maintenance & Engineering.
• Potentially a Site Based Position in Carlow; dependent on Covid-19 restrictions.
• Objective is to create an Asset Management Strategy (AMS) for the Project.
• Working on state-of-the-art equipment on a high-profile project.
• Working on building Asset Management Systems and Strategies for a state-of-the-art facility; Factory of the Future.
• Working as part of a strong and talented team.
• Responsible for the safe accomplishment of activities whilst following all statutory, environmental, regulatory (cGMP), corporate and departmental policies and procedures.
• Work in conjunction with the Production Equipment Subject Matter Experts (SMEs) and Reliability Excellence Team in the preparation, support during and close out of Failure Modes, Effects and Criticality Analysis (FMECA) Events.
• Manage all the equipment material gathered for each event, including; Preventive/Corrective Maintenance details, equipment performance info, Standard Operating Procedures (SOPs), Drawings, Vendor info, Spares info etc.
• Work closely with the FMECA Team to ensure that all outputs from the events are processed in a timely manner.
• Responsible for meeting predefined targets with respect to preparing documentation/data, participating in and following up on production related events for the Site’s Rx Program.
• Support the site’s Unplanned Downtime Governance process by collecting, transcribing and providing key data to stakeholders and work with the Production/Rx Team to transition to an OEE process from a manual D/T process.
• Required to comply with the company’s 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.
• Bachelors Degree or equivalent qualification; ideally in a related Engineering discipline.
• Prior experience working within an Engineering or Maintenance Department required, preferably in a pharmaceutical, medical or equivalent GMP environment.
• Knowledge of cGMP and GDP preferred.
• Proficiency in Microsoft Office and job-related computer applications required.
• Lean Six Sigma Methodology experience desired.
• Report, standards, policy writing skills required.
• Knowledge of maintenance systems, processing equipment and maintenance systems.
• Track record of implementing change initiatives.
• Data analysis.
• Demonstrable analytical and systematic problem solving skills.
• Training skills.
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