Validation Engineer
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| Job Type | Contractor |
| Area | Roscommon, IrelandWestmeath, Ireland |
| Sector | 15,31,36,42 |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1985 |
| Job Views | 130 |
- Description
- biopharmaceutical company based in Dublin.
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.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Owning the line qualification lifecycle document using risk-based verification approach (ASTM E2500)
Managing the vendor SAT testing and executing against verification test scripts
Overseeing of the Vendor VHP CD/PQ
Supervising the autoclave sterilization cycle (cycle development and PQ) for the format contact parts
Driving and execution of the air visualization studies
What you need to apply:
Bachelor’s degree required as a minimum
9+ Years of experience
Knowledge of the risk-based qualification approach, applied knowledge of ISPE C&Q and ASTM E2500
Experience of the filling isolator concept
Hands-on experience with installation and verification test execution
Non-touch-transfer technology experience
Understanding of the VHP cycle development and performance qualification
Autoclave sterilization of the porous loads knowledge
Good project management skills
Strong communication skills
