Engineer IT Compliance

Responsibilities

• Lead and execute compliance activities for IT systems, including plans, reports, testing, changes, and periodic reviews
• Serve as the primary point of contact for CSV-related topics, acting as a liaison between technology teams and the IT GRC unit
• Review and approve project documentation and GxP-impacted deviations to ensure appropriate CAPA implementation
• Contribute to the definition of compliance strategies and implement system-level compliance plans
• Manage gaps within the CAPA Management System and provide support for internal and external audits
• Establish trusted partnerships with IT technology functions to provide day-to-day operational support

Requirements

• University degree in Information Technology, Life Sciences, Pharmacy, Engineering, or an equivalent field
• Minimum of 3 years of overall IT experience
• Minimum of 5 years of relevant experience in the pharmaceutical industry, specifically within regulated functions like IT quality and compliance
• Solid understanding of global regulations and health authority expectations (CSV, Part 11, etc.)
• Experience with the lifecycle management of computerized systems in regulated environments (e.g., ERP/SAP, MES, LIMS)
• Strong understanding of ITIL, ITSM, and quality management in cloud-based regulated environments
• Excellent analytical, problem-solving, and communication skills

Benefits

• Flexible working arrangements including flexible hours and a vacation account
• Professional growth through digital learning, leadership development, and LinkedIn Learning
• Health and lifestyle support including a company bike and job ticket/Deutschlandticket
• Financial security through an employer-funded pension
• Support for various life phases, including childcare

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve global health.