Description
Role - Cleaning Validation EngineerType - initially 11 month contract
Location - Ireland
One of our global Pharmaceutical clients are looking for a professional to join their Technical Operations Validation team to validate and provide ongoing technical support to the filling processes at their Vaccines Formulation/Fill facility.
Key Responsibilities
Draft and execute cleaning master plans, protocols and reports.
Actively participate in the development of cleaning cycles and building robustness into the cleaning processes.
To co-ordinate and execute cycle development, cleaning verification and cleaning validation associated with the equipment process trains for the manufacture of sterile vaccines and biologics.
To collate and review data to set alarm limits from a process capability perspective.
To actively participate in cleaning studies, and review data from other Merck sites to leverage if possible to support the cleaning program.
Conduct recovery studies as part of analytical method validation to support cleaning studies.
Conduct swab and rinse sampling as part of the cleaning programs
Apply a risk based approach in matrixing equipment from a worse case perspective to support cleaning programs.
Apply a risk based approach in determining worse case products/conditions and proposing acceptance criteria.
Actively contribute to project teams.
Key Experience:
Cleaning Validation experience in vaccine or sterile product manufacturing (min 3 - 5 years)
Experience in IMB/FDA environment advantageous.
Strong technical writing and communication skills
Must be goal-oriented and able to manage risks.
Project management skills
To apply, please send in your CV.