Clean Utility Systems Expert

3 days ago


County Dublin, Ireland Team Horizon Full time

What You Will Be Doing

In this role, you will be responsible for the following:

  • Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation;
  • Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report);
  • Provide technical assistance during investigations and system design;
  • Coordinates and Supervises all C&Q activities on our 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;
  • Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

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.


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