#R-204819
issues and with EHS on Safety and Environmental issues
• Being the site contact (SME Subject Matter Expert) for external and regulatory audits.
• Rolling out training on systems for which the candidate is the designated SME / System Owner
• Driving Continuous Improvement in the performance elements of Systems owned
• Actively engaging in Work Centre Teams, as the SME for Equipment and Systems owned.
System Ownership responsibilities include:
• Measuring and maximizing the uptime of their systems.
• Monitoring of day-to-day performance of their assigned systems.
• Data trend analysis of all performance aspects of their systems and equipment to identify and proactively manage performance trends, including anticipating, solving or escalating problems as appropriate.
• Troubleshooting of performance trends.
• Risk assessments and mitigation projects relating to system performance.
• Ensuring the preventative maintenance schedule for their systems is successfully implemented.
• Driving predictive maintenance methodologies and best practice maintenance governance
• Ensuring that critical spare parts lists for their system are identified and appropriate levels of spares are maintained.
• The definition and scoping of all improvement activities relating to their systems
• Ownership of interactions, understanding of the interface of their systems with the BMS or PCS systems on site
• All design reviews associated with equipment purchases / changes to their systems
• All Quality System Triage sessions, investigations, deviations and CAPAs associated with their systems, including the ownership and completion of any RCAs
• The development and execution of FAT, SAT and IOQ protocols
• Representing F&E on site-based teams involved in implementing new technology, products or business processes to the site
• Reviewing and approval of changes to operating procedures and the change control process relating to their systems
• Owning and completion of any CMMS administrative WOs associated with their systems.
Basic Qualifications:
• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical).
• Experience in the Pharmaceutical or BioTechnology industries, in a direct or supportive Equipment Owner role, operating equipment and troubleshooting all types of utility or process systems, including electrical, mechanical and instrumentation experience, preferred.
.