The Utility Process Engineer will report directly into the Site Engineering Manager
This position is critical to the overall running of the site Utilities operation and is involved in the overall lifecycle of capital assets (designing, delivering, operating, maintaining, and decommissioning) in the most productive and cost-effective manner
The successful canadine will be the site SME for all black and clean utility processes. They will manage the day to day operation of the systems from an engineering and compliance perspective, ensuring uptime is maximised to support production requirements.
The candidate will have a proven track record of working with teams in a collaborative manner to delvier and achieve function and site goals.
This role is responsible for :
* Managing the daily operation of all site black and clean utility systems to ensure full compliance with operational needs
* Managing the maintenance systems associated with utility systems.
* Manage any outsourced facility contracts for hard and soft services associated with supporting the systems.
* Ensuring that budget adherence is achieved.
* Planning and executing site shutdowns as required to ensure systems are properly maintained and upgrades completed to critical site systems.
* Driving a continuous improvement mentality to ensure that industry leading uptime is achieved on all utility systems.
* Providing SME input into any new system upgrades or future capital projects.
Technical areas of coverage to include all site serviced utilities, including but not limited to:
* WFI (Water for Injection)
* Clean Steam System
* Purified Water Systems
* Gas boilers
* Low pressure hot water system
* Water treatment
* Air compressors
* Nitrogen generation
* Gas and electric consumption
* Fire Protection/Detection
* Gas Systems
Utility Process System Ownership:
* Continuously monitors the critical GMP systems and raises deviations, CAPA’s and change controls as required to address any non-conformances.in conjunction with quality and other stakeholders.
* Coordinates/Development/monitors activities the Maintenance Excellence program for utility systems
* Work with Engineering Manager to ensure Elastomer Change Out is performed on Utilities Equipment as scheduled through the CMMS system.
* Jointly responsible for achieving financial targets in support of business objectives.
* Act as the SME (Subject Matter expert) on all black and clean Utilities Equipment across the site to support daily operations and compliance audits as required.
* Make recommendation and implement continuous improvements on utility systems/equipment to improve performance, reduce downtime and improve efficiency.
* Liaise with the Engineering Shift team daily to review equipment performance on all Site Utilities Systems
* The Utilities Engineer will deputise for the Engineering Manager in such cases as per the job specification but is not limited to the job specification.
* Participates in economic analysis and feasibility studies as required and supports the start-up of new facilities/Utilities in the development of their maintenance strategy.
* Understanding of Basic Instrumentation and work with Instrumentation group to ensure calibrations are performed without issue and any investigations are carried out through the site deviation/change control program
Problem Solving / Continuous Improvements:
* Leads root cause analysis for equipment downtime.
* Develops and executes reliability studies and evaluations of equipment robustness.
* Work with automation team to support changes and upgrades to utility control systems as required.
* Improves maintenance processes. Recognizes and implements process improvements and cost reductions; creatively applies others’ ideas.
* Ensures subcontractors documentation are produced to site standards to ensure a smooth transition from commissioning to qualification when required.
* Provide a strategic look across equipment performance (downtime), material/component failure analysis, and changeovers (Methods- FMEA, Fishbone/Six Sigma/DMAIC Principles)
Educational / Technical Requirements:
* B.Eng or B.Sc. degree in Engineering or Life Sciences discipline.
* Strong knowledge of electrical and control systems an advantage.
* Familiarity with appropriate engineering codes.
* Familiarity with using BMS and PCS control systems for monitoring and reporting.
* Experience working within a HSA Regulated environment
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