Description
A Global Biotech organisation currently requires an experience Steam Validation Engineer to work at their fill finish facility in Ireland.You will be working alongside the Validation team starting up, validating and providing technical support to the filling processes at their vaccines formulation facility.
Key Responsibilities
-Coordinating and executing utility / equipment performance qualifications associated with sterile formulation / fill facilities.
-Participate in heat penetration/distribution studies associated with cycle development and PQ using Kaye thermal system and biological challenges
-Draft and review validation documentation and procedures.
-Execute, complete and track validation documentation to high standards.
-Actively contribute to project teams.
-Participate 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
-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.