Manager* Validation MS&T
Mainz, Germany | full time | Job ID: 8958
At the iNeST 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.
Your main responsibilities are:
- 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.)
What you have to offer:
- 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.
Your Benefits:
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
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 8958 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.