International Pharmaceutical Manufacturer seeks a Reliability Engineer.
About the role:
The Reliability Engineer will be responsible for developing and implementing a sustainable reliability program to reduce reliability risks. This role will implement a process to track production losses and abnormally high maintenance costs. Identify and implement projects using robust root cause analysis to reduce those losses or lower costs. This role will operate closely with projects, facilities and engineering teams to ensure optimised efficiency of equipment and assets, effective reliability processes are developed, and a cultural shift towards World Class asset management.
Duties may include:
·Implement the program in a structured approach in in-line with cGMP and GEP whilst bringing the Engineering, Production and Quality teams along in the journey to World Class asset management
·Identify and manage asset reliability risks that could adversely affect plant or business operations.
·Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
·Provide hands on technical engineering support, training and coaches others in relevant aspects of equipment performance.
·Be involved in the design and installation stages of projects for new assets and modification of existing assets to ensure on-going reliability.
·Perform analyses of assets including:
·Asset Utilization / MTBF (Mean Time Between Failures) / MTTR (Mean Time To Recover)
·OEE (Overall Equipment Effectiveness) / TEEP (Total Effective Equipment Performance)
·Remaining useful life
·Other parameters that define operating condition, reliability and costs of assets
·Spare Parts strategy
·Provide training and coaching on the following:
·Modern maintenance strategies
·Develop engineering solutions to reduce repetitive failures and other problems that adversely affect plant operations. These problems include capacity, quality, cost or regulatory compliance issues.
·Have a working knowledge of Statistical Process Control & Six Sigma (6s) Methodology
·Be familiar with implementing typical reliability risk assessment tools including.
·PHA - Preliminary hazards analysis
·FMEA - Failure modes and effects analysis
·RCA - Root Cause Analysis (including FTA - Fault tree analysis & ETA - Event tree analysis)
·RCM - Reliability Centred Maintenance
·CA - Criticality analysis
·SFMEA - Simplified failure modes and effects analysis
·TPM - Total Productive / Predictive Maintenance
·Professionally and systematically defines, monitors and reviews Asset Maintenance Plans in conjunction with equipment SMEs to:
·Ensure value-added preventive maintenance tasks
·Correctly deploy predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems
·Manage and ensure appropriate support contracts are in place for critical equipment as required.
·Develop reliability standards, design standards, engineering procedures and standard operating procedures in conjunction with Process Engineering.
·Works with Capital Projects to ensure the reliability and maintainability of new and modified installations. Participates in the final check out of new installations. This includes factory and site acceptance testing that will assure adherence to functional specifications.
·Applies value analysis to repair/replace, repair/redesign, and make/buy decisions.
Skills and experience:
·Expert working knowledge of Reliability Tools:
·Knowledge of: Aseptic Filling Lines, Centrifugation, Lyophilisers, Autoclaves, Sterilisation and Depyrogenation Systems, Clean Room Technology, Ultra-Filtration, and Packaging Lines.
·Knowledge of Quality Management Systems within a Pharmaceutical GMP Environment
·Knowledge of Engineering Change Control processes, and how they apply during major or minor projects.
Knowledge of Predictive Maintenance techniques and how to apply them in the field