As part of the global QA team, this role is responsible to support the validation of global computerized system in the BioNTech network.
Your Contribution:
* You will support global validation projects of from a QA perspective to ensure that corporate computerized systems are validated and meet BioNTech's quality system and current regulatory requirements
* You will oversee pharmaceutical quality system processes (e.g., CAPA, deviation, change control, training) for corporate GxP-critical applications, IT infrastructure, and projects, ensuring effective collaboration between global and local levels
* You will support the development, harmonization, optimization, and maintenance of CSV-related quality processes globally and across multiple manufacturing sites and areas, including Global Standards/Policies and SOPs, ensuring compliance with applicable regulatory requirements
* You will contribute to audit and inspection readiness within your area of responsibility, presenting global QA oversight and validation activities and processes during inspections
A Good Match:
* You hold a degree in pharmacy, chemistry, biology, or a related scientific field, or equivalent industrial qualification and experience
* At least 3 years of experience in Quality Assurance, particularly in Computer System Validation (CSV) / Computer System Assurance (CSA) and Data Integrity
* You have a solid understanding of GxP regulations and pharmaceutical quality systems, with experience in global and local project environments
* You have hands-on experience in validation of systems like SAP, Laboratory Information Sysmtems (LIMS), and Manufacturing Execution Systems (MES)
* You have first audit experience and demonstrate strong analytical and proactive capabilities, as well as strong problem-solving skills to effectively drive quality improvements
* You are motivated to work in an agile environment, embracing change and continuous improvement
* You are analytical and proactive, with strong problem-solving skills to drive quality improvements effectively
* You are fluent in English, and proficiency in German is considered a plus
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 1 PM to 3 PM CET).
Job ID 11236 (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.