Clean Utilities Engineer

  • Cork
  • Permanent
  • JO-1811-63972_1546421909

Summary

Clean Utilities Engineer


The purpose of this role is to be a clean utilities Engineer supporting the Sterile Integrated Process Team. This is a key role to ensure that the day to day operations of the Utilities provided to the IPT are compliant.

Role:

  • Support audits on clean utility systems.
  • Be responsible for adherence to site and corporate QMS for 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.
  • Use Lean principles to deliver a cost-efficient operating model for commercial production while not compromising EHS and Quality standards.


Requirements:

  • 5 years' experience in the Pharmaceutical industry or a similar operating environment.
  • Degree or 3rd Level Qualification (Engineering), Masters preferred.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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