C&Q Engineer

2022-05-12 12:10:202049-10-10Team Horizon
Job TypeContractor
AreaWestmeathWestmeathIreland
SectorEngineering
Start Date
AdvertiserHilda Lynn
Telephone+353 98 33013
Job Ref#1002468
Job Views140
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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