Sr. Utilities Engineer – System Owner

Amgen; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen is seeking a Site Utilities Engineer to own and manage critical utility systems on site. You will act as SME for system performance, safety, and regulatory interactions, driving continuous improvement and proactive maintenance.

The role involves collaboration with Manufacturing, QA, Labs and EHS, training, and leading cross-functional audit responses. A strong engineering background with pharma utilities experience is essential.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical).
• Experience in Pharmaceutical or BioTechnology industries in equipment owner roles, operating and troubleshooting utility/process systems.

Responsibilities

• Lead and own troubleshooting for assigned Utility & Equipment Systems.
• Lead RCAs, investigations and deviations for operational issues.
• Coordinate with Manufacturing, QA, Labs and EHS on performance and safety issues.
• Serve as site SME for external and regulatory audits.
• Provide system owner training and oversee system-related SOPs and procedures.
• Plan shutdowns for maintenance and ensure preventive maintenance schedules.
• Drive continuous improvement in system performance and uptime.
• Engage in Work Centre Teams as SME for equipment and systems.
• Monitor day-to-day performance and analyze data trends for proactive actions.
• Define improvements and manage interfaces with BMS/PCS systems.
• Lead FAT, SAT and IOQ protocol development and execution.
• Represent F&E on site teams for new technology and processes.

Skills

GMP systems ownership

statistical analysis

continuous improvement

problem solving

automation interfaces

troubleshooting

Education

Bachelor's degree in Engineering

Job description

This position will be part of the Site F&E (Facilities & Engineering) group and the successful candidate will be System Owner for certain Utilities Equipment Systems on site within the group. He/She reports 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.

Scope:

• Plant Utilities including Steam Boilers, and Low Pressure Hot Water Systems
• Plant Utilities Water Systems including Potable Water, Industrial Water, Cooling Tower Water, Chilled Water, Fire Water.
• Fire Protection, Fire Detection and Gas Detection Systems
• Electrical Systems including General Power, Emergency Power, UPS Power
• GMP Clean Utilities Water Systems, including Purified Water, Water For Injection and Clean Steam
• GMP Gas Systems including Nitrogen, Compressed and Process Air
• Process Waste

Responsibilities include:

• Lead, primary owner, responsible for troubleshooting issues relating to the systems owned.
• 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, relating to the Systems owned.
• 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
• Planning shutdown interventions for maintenance on the systems owned.
• Driving Continuous Improvement in the performance elements of Systems owned
• Actively engaging in Work Centre Teams, as the SME for Equipment and Systems owned
• 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.

Amgen is an equal opportunities employer