Overview This position is part of the Site F&E (Facilities & Engineering) group, and the successful candidate will be the System Owner for certain Equipment Systems on site within the group.
They report to the Sr.
Manager – Utilities Engineering.
The candidate will have knowledge and proficiency in a variety of areas, including GMP and nGMP systems, the use of statistical analysis tools, continuous improvement methodologies, problem-solving, and applied engineering relating to systems and equipment and their associated automation systems & interfaces.
The chosen candidate would typically be accountable for the following activities (but not exclusively):
Lead for RCAs, investigations, deviations for any operational issues related to the Systems owned.Liaison with Manufacturing, QA, and Labs on performance 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.
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