Thermal Systems Validation Engineer

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