Commissioning & Qualification Engineer

  • Contract
  • Dublin

Website TPM04800

Summary:
Our Client is a biopharmaceutical company looking to hire a Commissioning and Qualification (C&Q) Engineer for various capital projects. Ensuring the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Responsibilities:

  • Coordinates and Supervises all C&Q activities.
  • Generate C&Q planning documents detailing overall strategy for the project.
  • Develops the master list of C&Q test documents and activities.
  • Generates all C&Q summary reports.
  • Ensures the C&Q schedule is developed and maintained.
  • Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr).
  • 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.
  • 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.

To apply for this job email your details to orla.daly@tandempm.ie.