Manager Validation MS&T
Mainz, Germany | full time | Job ID:8958
At the Pilot Facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The Pilot Facility is designed for high-throughput production.
Creation and maintenance of the validation concept for the Pilot Facility
Planning of validation activities for the establishment of new products and optimization of existing processes, including the creation of validation reports
Technical leadership in validation activities (process validation, cleaning validation, etc.)
Responsible for training the operational departments on the validation activities
Creation and maintenance of process-relevant documents (process risk analyses, process descriptions, etc.)
Degree in Pharmacy, Biotechnology, Natural Sciences, or Engineering
4-5 years of relevant experience in a regulated GMP environment
Professional experience in process validations of biotech products
Solid knowledge of US and EU regulations and experience in dealing with respective authorities
Excellent communication and organizational skills
Detail-oriented, excellent problem-solving skills, and critical thinking abilities
Fluent in German and English
Please note that this position is a limited replacement for parental leave. It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare