Commissioning & Qualification Lead

  • Contract
  • Dublin

Website TPM04801

Our client is a biopharmaceutical company based in South Dublin, is looking for a Commissioning and Qualification (C&Q) Lead for a portfolio of Capital Projects. Lead a team of C&Q engineers to ensure the C&Q activities associated with a portfolio of capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.


  • Coordinates and supervises all C&Q activities.
  • Approves C&Q planning documents detailing overall strategy for the project.
  • Develops and approves the master list of C&Q test documents and activities.
  • Reviews and approves all C&Q summary reports.
  • Ensures the C&Q schedule is developed and maintained.
  • Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
  • Pre‐Approval and Post approval of C&Q test documents.
  • Manages Daily C&Q coordination meetings.
  • Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
  • Ensures Start-up 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).

Qualifications & Experience:

  • 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.
  • Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
  • Knowledge of safety, GMP and environmental regulatory requirements.
  • Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry.

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