Description
Urgent Senior Process Engineer/Cleaning Validation Engineer Required Frankfurt• Ensure process validation is conducted per regulatory and client requirements
• Help develop and maintain validation program documents including SOPs and Master Plans.
• Lead the development and execution of process validation studies, data analysis and final reports e.g. hold studies, resin lifetime etc.
• Lead the development and execution of engineering studies in support of PV e.g. Mixing studies, Resin Blank Runs etc.
• Ensure prerequisites for process validation are complete to satisfaction.
• Providing validation support in deviation investigations and change control.
• Can be requested to help in other validation efforts at the CMO per request.
• Ensure compliance related to validation activities with other groups to meet established validation policies and procedures and cGMP requirements
Requirements
• Bachelor’s degree in Science or Engineering and 12 years of operational validation experience in a pharmaceutical, or biotechnology industry
• Experience in process validation and cleaning validation is a must.
• Experience in a multiproduct pharmaceutical/ biotechnology manufacturing facility is a plus.
• Experience in a CMO environment is a plus.
• Fluent in German
• Looking to hire in the next 1 month (preferably).