Clean Utilities Engineer
Mayo, Sligo
Job Type:
Mayo, Sligo

Clean Utilities Engineer

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:

Clean Utilities Engineer

As a Clean Utilities Engineer, the primary responsibilities revolve around overseeing and optimizing various clean utility systems.  You will provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment, and controls.

Job responsibilities

  • Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.
  • Leadership of clean utility and validation activities during project life cycle.
  • Participate and lead clean utility project implementations.
  • Support clean utility equipment installation, integration and co-ordinate vendor supervision as required
  • The Clean Utilities Engineer will take ownership for clean utilities (Purified Water, Water for Injection, Clean Steam, High Quality Compressed Air and Nitrogen Distribution) and to work as a team member in line with all safety, regulatory and organizational requirements.
  • Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
  • Present on clean utility area in regulatory inspections ensuring successful outcomes
  • Develop and modify procedures as needed to support the clean utility area
  • Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements
  • Support the Production Team in ensuring that utility equipment is maintained to meet requirements
  • Investigate process exceptions or equipment malfunction incidents affecting the process.

Education & Key Requirements

  • Degree educated in a engineering, technical or science discipline.
  • 5+ years experience within the pharmaceutical or biotech sectors.
  • 3+ years of relevant experience in clean utility.
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
  • Strong analytical and problem-solving abilities.

We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Clean Utilities Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.


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