Validation Engineer
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| Job Type | Contractor |
| Location | Westmeath |
| Area | RoscommonWestmeath |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2468 |
| Job Views | 299 |
- Description
- Validation Engineer – Team Horizon
We are seeking applications for an experienced Validation Engineers to support New Product Introduction in our client’s Biologics Facility in the Midlands. As the Validation Engineer, you 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:
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
Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
0Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
1Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
2Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
3
- 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
