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Clean Utilities Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Cork
  • Sector: Science
  • Date posted: 24/10/2018
  • Job reference: BBBH91241

Clean Utilities Engineer

Summary

My client, a global pharmaceutical company based in the North West is looking take on an experienced Clean Utilities Engineer as part of a planned expansion. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

The primary 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. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical industry.

Key Responsibilities

  • 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.

Continuous Improvements

Use Lean principles to deliver a cost efficient operating model for commercial production while not compromising EHS and Quality standards.

Coaching and Training

Coaching others by sharing your skill-set and expertise. Identifying talent and coaching and nurturing them to develop and perform at their maximum potential.

Qualifications

  • 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.
  • At least 5 years' experience in the Pharmaceutical industry or a similar operating environment.

Skills/Competencies

  • 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)
  • 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.

Ready for an exciting change?

Please submit your CV to Jack on jack.conway-kenny AT experis.ie, or 01-6455250 for more info!

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