Job Description:
Validation Engineer
This role will be part of the Technical Services team starting up, validating and providing on going technical support to the filling processes at our clients Vaccines Formulation / Fill facility.
- 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.
- Audit preparation and representation of the Technical Services department during regulatory body inspections as required.
< 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 flexible and able to manage multiple priorities.
- Must be goal-oriented and able to manage risks.
- Project management skills
< Education:
- Degree level qualification in Science or Engineering.
Please forward c.v in the strictest of confidence to Martin OLeary
moleary@brunel.ie or call on 051-309652 for further information.