18317 – Cleaning Utilities Engineer – Cork Contractor

Purpose

The purpose of this role is to be a clean utilities Engineer supporting site Utilities. This is a key role to ensure maximum uptime of Utility equipment are provided to the Site.

Responsibilities

• Be responsible for adherence to site and corporate QMS for clean Utility Systems
• Support audits on clean utility systems.
• Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
• Complete periodic reviews and other compliance documentation aligned with the site QMS.
• Review and approve Utility & HVAC modifications, change requests, and SOP’s.
• Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan
• Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.
• The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems).
• Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.
• Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
• Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.
• Responsible for supporting a culture of Continuous Improvement by deploying Lean principles to deliver a cost-efficient operating model for commercial productionwhile not compromising EHS and Quality standards.

Requirements

• Degree or 3rd Level Qualification (Engineering), Masters preferred.
• Desirable to have qualification in Reliability Engineering and/or Project Management.
• Bachelor of Engineering in a related discipline.
• > 5 years’ experience in the pharmaceutical industry or a similar operating environment.
• Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS & GMP)
• Very Strong Leadership Skills
• Technical knowledge
• Ability to respond to competing priorities
• Communications skills
• Problem solving skills
• Relevant experience in pharmaceutical production management.
• Very strong knowledge of industrial safety standards.
• Beneficial to have previous operational knowledge within Drug Product, Drug Substance or Utilities.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing or Quality etc.)
• Knowledge and experience in applying Six Sigma and Lean Methodologies.
• Demonstrated leadership and change management skills with a continuous improvement focus.
• Proven experience in reducing energy consumption through innovative technology and lean thinking.
• Demonstrated understanding of Project life Cycle, from design through to commissioning/qualification & retirement
• Strong talent developer, proven capability of fostering engineering/technical talent
• Beneficial to have strong networks within Engineering/Technical community
• Customer Focus – proven ability to delight customers & end users.