Specialist Manufacturing Processes - Visual inspection and Packaging (Mainz, RP, DE, 55131) en BioNTech

Mainz, Germany   |   full time   |   Job ID: 8998 

At the individualized neoantigen specific therapy facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The role of Specialist Manufacturing Processes supports the daily operations in production to enable smooth production. As support for the subject matter experts (SMEs), the role holder possesses in-depth process knowledge in the area visual inspection and packaging. The Tasks include root cause analysis and risk assessment for process deviations and the definition of corrective and preventive measures. The Specialist Manufacturing Processes further more coordinates change control.
 
Your main responsibilities are: 

•    Support for subject matter experts (SMEs) regarding product and process knowledge for the production of individualized cancer therapy (labeling, packaging and visual inspection) during the project phase
•    Support and execution in device qualification according to GMP requirements and internal SOPs
•    Handling of deviations occurring during the production process
•    Creation of area-specific documents (e.g. SOPs, working procedures, forms)
•    Definition and implementation of corrective and preventive actions (CAPA management)
•    Coordination of change procedures in production (Change Owner)
•    Taking over device related responsibilities

What you have to offer:

•    University degree (Bachelor or Master) in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
•    2 years of experience in manufacturing/production or relevant experience in the topics of GMP documentation, visual inspection and packaging and device qualification, ideally in a biotech or pharmaceutical company 
•    Good knowledge of EU GxP regulations
•    General understanding of technical processes
•    Experience in deviation, CAPA and Change management
•    High carefulness and accuracy in the way of working, conscientiousness, and detail-orientation
•    Refined colloquial and correspondence skills in English (B2) and in German (B2)

Are you ready to take on responsibilities with continuous support from your team and manager, while enjoying an independent work style without micromanagement?
Then apply for our position!

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 8998 (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.