C&Q Engineer

Berkley Group

  • Dublin
  • Contract
  • Full-time
  • 2 months ago
C&Q EngineerClean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.Key Responsibilities:
  • 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 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.
  • Assist in the development of User Requirement Specifications (URS's) and Quality
  • Risk Assessment for Equipment and Automated Systems (QRAES).
Education / Experience:
  • 3+ 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.

Berkley Group