JOB OFFER

JOB DETAILS

Title:
Project Engineer – Clean Utilities
Location:
Mayo, Sligo
Job Type:
Mayo, Sligo

Project Engineer – Clean Utilities

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. 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 are hiring for a Project Engineer – Clean Utilities  for the Sligo region.

Job Requirements

  • 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.
  • Leadership of clean utility and validation activities during project life cycle.
  • Participate and lead clean utility project implementations.
  • Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.
  • Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
  • Support clean utility equipment installation, integration and co-ordinate vendor supervision as required
  • Present on clean utility area in regulatory inspections ensuring successful outcomes
  • Support the Production Team in ensuring that utility equipment is maintained to meet requirements
  • Investigate process exceptions or equipment malfunction incidents affecting the process.
  • 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
  • Develop and modify procedures as needed to support the clean utility area

Education & Key Requirements

  • Bachelor’s Degree in a related science or engineering discipline.
  • 4years plus experience within the pharmaceutical or biotech sectors
  • Hands on expertise required in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
  • Ability to think logically and be proactive.
  • Flexible and self-motivated.
  • Strong interpersonal skills are required.

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