C&Q Engineer


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https://www.teamhorizon.ie/job-search/528-cq-engineer/engineering/westmeath/job2022-05-12 12:10:201970-01-01Team Horizon
Job TypeContractor
AreaWestmeath, IrelandWestmeathIreland
SectorEngineering
Start Date
AdvertiserHilda Lynn
Telephone+353 98 33013
Job Ref#1002468
Job Views293
Description
C&Q Engineer – Team Horizon

We are seeking applications for an experienced C&Q Engineers to support New Product Introduction in our client’s Biologics Facility in the Midlands.  As the C&Q Engineer will be responsible for Installation and Operational tests execution, protocol generation and results reporting on process equipment and utilities systems.

 

Why you should apply:



  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


 

What you will be doing:



  • 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 Verification Testing


  • 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


  • Change Control


 

What you need to apply:



  • Bachelor’s Degree or Relevant Experience


  • Typically, 3+ years Validation engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment


  • Experience in MS Office, MS Project, Change Control & Document Management Systems


  • Ability to work to tight deadlines in a fast-moving environment


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