Aseptic Manufacturing Expert

1 day ago

Dublin, Dublin City, Ireland beBeeEngineering Full time €5,500 - €6,500
Biotechnology CQV Professional

We seek an accomplished Biotechnology Commissioning and Qualification (CQV) expert to join our dynamic team.

This is an exceptional opportunity to gain experience in a state-of-the-art aseptic manufacturing facility, one of the most advanced in Ireland.

The successful candidate will be responsible for owning projects, equipment, and documentation, ensuring seamless qualification processes.

Main Responsibilities:

  • Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects
  • Ensure C&Q activities associated with capital projects are completed safely, on schedule, and compliant with GMP and Quality Requirements
  • Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation
  • Generating, reviewing, and executing documents for both company and vendors
  • Collaborating closely with system owners, QA, and other stakeholders
  • Provide technical assistance during investigations and system design
  • Coordinates and Supervises all C&Q activities on their systems
  • Ensures the C&Q schedule is maintained
  • Manages Daily C&Q coordination meetings
  • Responsible for Tracking and Reporting of C&Q status and risks/issues
  • Ensures Startup of equipment/utilities is completed in a safe and coordinated manner

Requirements:

  • 6+ years experience in Engineering or Commissioning and Qualification Management
  • Technical qualification at third level or equivalent in Engineering
  • Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred
  • Knowledge of safety, GMP and environmental regulatory requirements
  • Demonstrated strong Communication and Leadership skills
  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
  • Familiarity with paperless validation systems
  • Experience in commissioning and qualification of process equipment and or Utilities, both would be a preference
  • Experience in vendor documentation and execution, both onsite at factories and at vendor sites
  • Experience in the entire commissioning and qualification process, from URS to QSR (Qualification Summary Reports)
  • Experience with Deviation/Discrepancies
  • The candidate should be capable of managing multiple different projects simultaneously

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