Validation Engineer (CQV)
LS-1802
Open
The role
A large-molecule manufacturing site in north Dublin is expanding biologics capacity and building out the validation team for the duration of the project. This is a twelve-month contract with a strong likelihood of extension into the second phase.
You would own commissioning and qualification activity for a defined equipment scope: protocol authoring, execution, deviation management and the final reports. The scope covers upstream process equipment and the associated clean utilities, working within the site’s existing validation master plan.
The site is fully on-site by necessity. The validation team is around fourteen people, well run, and this is a project where the documentation standard is taken seriously.
What you will need
Three or more years of CQV or validation experience in a GMP manufacturing environment
Authored and executed IQ, OQ and PQ protocols independently
Familiarity with GAMP 5 and a risk-based approach to qualification
Experience with clean utilities: WFI, clean steam, process gases
Comfortable managing deviations and change controls through a site quality system
Degree in a relevant engineering or science discipline
Available within four weeks
What is on offer
€450 to €520 per day depending on experience
Twelve-month initial contract with a strong likelihood of extension
Structured project with an experienced validation lead
Free on-site parking and subsidised canteen
Weekly payroll through our own compliant contractor arrangement
Apply for this role
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