2022-419 – Reliability Engineer – Waterford Full Time

Purpose

As a Reliability Engineer, you will provide Technical support to the Production Department on reliability improvement elements, as directed by the site’s Reliability Excellence Program, including the management of the production Predictive Maintenance system, building of Bill of Materials (BOMs) for Critical Pre Filled Syringe Equipment, progressing the build of critical spare parts, facilitating Failure Modes, Effects & Criticality Analysis (FMECA) Events within PFS, and generating/providing key data for Equipment Performance Reviews on Critical production Equipment.

Responsibilities

• Responsible for the safe accomplishment of activities whilst following all statutory, environmental, regulatory (cGMP), corporate and departmental policies and procedures.
• May be required to perform other duties as assigned.
• Represent the Production Team on the Site’s Reliability Excellence Program Core Team.
• Responsibility of production equipment Predictive Maintenance system.
• Responsible for progressing the build of Bill of Materials (BOMs) on Critical Equipment within production.
• Support the facilitation and follow up requirements of the Equipment Performance Review (EPRs) on Critical Equipment within production.
• Responsible for progressing associated build work to ensure critical spare parts that have been identified are progressed to the point of order with on-site vendor.
• 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.
• Maintenance details, equipment performance info, Standard Operating Procedures (SOPs), Drawings, Vendor info, Spares info etc.Preventive/CorrectiveManage all the equipment material gathered for each event, including.
• 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/ Team.
• Leadership activities including selection, development, coaching and day to day management.
• 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 with Maintenance Planner to optimize and review PM’s.

Minimum Qualifications and Experience

• Degree in an Engineering discipline.
• 3 or more years’ relevant experience in a highly regulated GMP environment.
• Strong problem-solving skills.
• Strong documentation/protocol generation and execution skills.
• Experience of Sterile Manufacturing Operation an advantage.
• Experience in syringe filling would be a distinct advantage.