Sr. Utilities Engineer – System Owner

Amgen; Dún Laoghaire; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen seeks a System Owner for Utilities Equipment within Site F&E to lead troubleshooting, RCA investigations, deviations, and CAPAs for critical utility systems on site.

The role requires coordinating with Manufacturing, QA, Labs and EHS, owning maintenance planning, performing data trend analysis, and driving CI for uptime and performance of GMP/ ngMP systems.

Qualifications

• Bachelor’s degree in Engineering required.
• Experience in the Pharmaceutical or Biotech industries with utility or process systems including electrical, mechanical and instrumentation exposure preferred.

Responsibilities

• Lead as System Owner for utilities equipment and related automation.
• Liaise with Manufacturing, QA, Labs and EHS on performance and safety issues.
• Act as SME for external and regulatory audits and training.
• Plan shutdown interventions and drive continuous improvement in system performance.
• Manage preventive and predictive maintenance and ensure critical spare parts lists are maintained.
• Develop and execute FAT, SAT and IOQ protocols for equipment changes.

Skills

GMP/nGMP systems

Troubleshooting

Data trend analysis

Continuous improvement

Regulatory audit SME

Education

Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical)

Tools

CMMS

BMS/PCS interfaces

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:

The Utilities Systems for which the successful candidate will be responsible includes some (but not all) of the following:

• 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:

The chosen candidate would typically be accountable for the following activities:

• 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_