Description
A Global Biotech organisation currently require 3 x Cleaning Validation Engineers to be part of the Technical Operations Validation team, starting up, validating and providing ongoing technical support to the filling processes at their Vaccines Formulation / Fill facility in Ireland.Key Responsibilities
-To co-ordinate and execute utility/equipment Performance Qualifications associated with a sterile Formulation/Fill facility.
-To actively participate in heat penetration/distribution studies associated with cycle development and PQ using Kaye thermal system and biological challenges.
-Participation in the drafting and reviewing of validation documentation and procedures.
-Accountable for the execution, completion and tracking of validation documentation to a required standard.
-Actively contribute to project teams.
-Partake in cleaning validation and process validation studies.
Key Experience
-Validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 - 5 years)
-Thermal mapping experience using Kaye systems
-Cleaning Validation experience
-Experience in IMB/FDA environment advantageous.
-Strong technical writing and communication skills
-Must be goal-oriented and able to manage risks.
-Project management skills
Education
-Degree level qualification in Science or Engineering.