C&Q Engineer

  • Contract
  • Athlone

Website TPM04230

Summary:
Our client is looking for experienced a C&Q engineer to support New Product Introduction in their biologics facility in Athlone.

Responsibilities:

  • C&Q Engineer will be responsible for Installation and Operational tests execution, protocol generation and results reporting on process equipment and utilities systems.

Qualifications & Experience:

  • Degree qualification required in a relevant discipline.
  • 5 years’ experience required in a GMP environment ideally within biologics.
  • Understanding of the ASTM E2500 Qualification Requirements.
  • Understanding of the system/equipment qualification lifecycle: URS to Operational phase.
  • Direct Experience with hands on execution of System/equipment Mechanical Completion, Installation Verification and Functional.
  • Understanding of the Quality Risk Management within qualification requirements.
  • Understanding of manufacturing equipment used in Biologics and Drug Product Processes.
  • Understanding of the Utilities Systems and systems and their CQAs (Clean Steam, WFI, HVAC, process gasses).
  • Understanding of the Aseptic and Biologics Manufacturing processes and contamination control.
  • Understanding of the BMS systems and Automation architecture.
  • Understanding of the ASME BPE – Bioprocessing Equipment Requirements.
  • Understanding of the Quality System Elements: deviation, CAPA, calibration, preventative maintenance and change control.

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