Company Profile:
Our client a leading multinational Biopharmaceutical organization based in Dublin are hiring for a Utilities Engineer on an initial 12 month contract basis. The company in question have a steady pipeline of products in development and are therefore expanding their operations. It would be based on a highly modernized site with cutting edge equipment which has seen sizeable investment recently.
Job Summary:
The Site Utility Engineering SME will be a Utility System Owner for Black and Clean Utilities. The SME will provide engineering support for specific assigned plant (Black or Clean) Utility infrastructure, systems and equipment across the site.
Core Responsibilities:
- Ensuring all the systems are in compliance with all Regulatory requirements including Quality cGDP/GMP’s, EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.
- Developing user requirements for new equipment and modifications to existing equipment and systems from concept through supporting installation with the collaboration of stakeholders.
- Developing, reviewing and updating the CMMS data, calibration data sheets, spare parts requirements, PMs, PdMs, job plans etc. to ensure that all maintenance schedules are designed to deliver cost effective, efficient reliability based maintenance programmes maximizing uptime.
- Performing and facilitating root-cause failure analysis (Cause Mapping) on chronic/critical/high impact failures.
- Minimizing unscheduled equipment downtime through effective preventative and predictive maintenance programs and rapid response to equipment failure.
- Using the CMMS, review and accept maintenance reports from Vendors and contractors, develop action plans etc. to address any issues. Raise CMs/PMs/Pdm etc. to ensure the issues are appropriately addressed.
- As area owner support all compliance - complete risk assessments, RCA investigations, identify appropriate CAPAs etc. to ensure no re-occurrence of issues.
- As Equipment and System owner be the owner of any change controls associated with the systems etc.
- Supporting audits as the System SME as required.
- Establishing high performance standards including development of appropriate metrics to track running costs, efficiency, uptime etc. for all equipment and systems.
- Developing budget for annual operation and any improvements/modifications/projects related to assigned utility equipment.
- Developing/implementing new capital project scopes, performing project management for equipment related modification projects on assigned systems as required.
Essential Requirements:
- The candidate will hold a minimum of a Level 8 BEng qualification in an engineering discipline.
- 5 years of experience working in pharmaceutical manufacturing facilities in a maintenance engineering or utilities role.
- Must be a team player prepared to lead, work effectively and efficiently in a team-based environment.
- Demonstrated ability to provide solutions that reflect understanding of business objectives and cost implications.
- Detailed knowledge and experience in operating and design of Utility equipment and systems.
- Detailed knowledge and experience in the pharmaceutical/biopharmaceutical industry, with in-depth knowledge of regulatory requirements (safety and quality).
- Experience dealing with regulatory agencies.
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