Thermal Mapping Validation Engineer is required for a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the sites laboratory, filling, packaging and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
As Validation Engineer you will:
o Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs).
o Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
o Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
The Validation Engineer will require:
o Bachelor of Science/Engineering degree or equivalent.
o Knowledge of cGMP’s and other worldwide regulatory requirements.
o Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system t
o Bio tech/Pharma background circa 2-4 years min
Call Kathy in LSC on 0214777 329 to discuss this Thermal Mapping Validation Engineer role in more detail or apply directly via this advert.