Thermal Systems Validation Engineer
| Job Type | Contractor |
| Area | Westmeath |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Job Ref | #2320 |
| Job Views | 183 |
- Description
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
