Thermal Systems Validation Engineer

2022-01-21 12:04:182049-06-21Team Horizon
Job TypeContractor
Start Date
AdvertiserHilda Lynn
Job Ref#2320
Job Views183

We are seeking applications for an experienced Thermal Systems Validation Engineer to join our client site in Athlone on an initial 12-month contract.  This role reports to the Senior Manager for Validation.
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:

  • Direct Experience with hands on qualification of Steam Sterilization Autoclaves and porous loads
  • Understanding of the EN285 Requirements and testing
  • Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
  • Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization
  • Understanding and handling of the Biological Indicators used for Steam Sterilization
  • Understanding of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs
  • Direct Experience with hands on for SIP qualification
  • Understanding of the Filter Integrity Testing requirements for SIP applications
  • Direct Experience with hands on qualification of Depyrigenation Tunnel
  • Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat)
  • Direct Experience with execution of Control Temperature Units and qualification requirements
  • Direct Experience using thermal acquisition systems
  • Understanding of the Aseptic Manufacturing processes
  • 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
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