Beschreibung
Our global pharmaceutical client is looking for a Cleaning Validation Engineer to support the introduction of a new product to their fill/finish facility. This role will be to support the validation of a new cleaning process on the line.Key Responsibilities
• Carry out a Failure Mode and Effects Analysis (FMEA)
• Create cleaning master plans, protocols and reports.
• Write validation master plan including sampling, calculations, set up methods of how to clean, processes and required resources.
• Actively participate in the development of cleaning cycles and building robustness into the cleaning processes.
• Conduct swab and rinse sampling as part of the 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 powder product manufacturing
• Experience in GMP/FDA environment, essential.
• Strong capabilities in writing documentation surrounding cleaning validation.
• Experience carrying out FMEA
• Knowledge of swabbing and rinse sampling techniques as part of the cleaning program
• Excellent communication skills
• Must be goal-oriented and able to manage own time.
Education:
• Degree level qualification in Science or Engineering.
Languages:
• German and English language skills desired.