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.