IT Compliance Engineer

BioNTech SE

Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.

Posted 4/19/2026full-timeMainz • 🇩🇪 GermanyMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

CloudERPITSM

About the role

Key responsibilities & impact

Execute compliance activities for systems, such as plans, reports, tests, changes, periodic reviews, and deviations
Provide necessary support to meet regulatory and information security requirements for regulated systems projects
Serve as the primary contact for CSV-related matters for GxP-computerized systems and act as a liaison between technology-based solutions and the IT Compliance on IT GRC unit
Review and approve project-related documents for GxP relevant systems, including determining GxP-applicability for all GxP- and non-GxP relevant systems
Establish a trusted partnership with the assigned IT technology-based function, understanding business drivers, and provide required day-to-day operational support
Review and approve GxP-impacted deviations, ensuring appropriate CAPA implementation
Contribute to the preparation of compliance strategies and execute plans for systems associated with respective functions
Review and approve periodic review reports for GxP computerized systems and manage any gaps within the CAPA management system
Provide audit support as assigned and offer necessary compliance support for any resulting CAPAs

Requirements

What you’ll need

University degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent level
A minimum of 3 years of overall IT experience
A minimum of 5 years of relevant experience in the pharmaceutical industry and in particular within regulated functions such as IT quality and compliance
Solid understanding of global regulations and health authorities’ expectations governing computerized systems (CSV, Part 11, etc.)
Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments
Experience in quality management of premises and cloud-based regulated environments
Highly experienced in the operational management of GxP-solutions, including its related technologies to support the operation
Good understanding in system application management, its quality support approach and industry best practices (ITIL, ITSM, etc.)
Experience in the development, implementation and lifecycle management of key computerized systems in pharmaceutical development, manufacturing, quality, commercial and infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.)
Strong analytical and problem-solving mindset and the ability to think critically and strategically
Proficient conflict management skills to mediate and resolve disagreements between stakeholders
Excellent written and verbal communication skills for clear communication, content delivery, and stakeholder interaction.

Benefits

Comp & perks

flexible hours
vacation account
Digital Learning
Performance & talent development
leadership development
Apprenticeships
LinkedIn Learning
Company bike
Job ticket
Deutschlandticket
Employer-funded pension
Childcare

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

compliance activitiesGxP-computerized systemsCAPA managementquality managementlifecycle managementsystem application managementCSVPart 11ITILITSM

Soft Skills

analytical mindsetproblem-solvingcritical thinkingstrategic thinkingconflict managementcommunication skillsstakeholder interactionoperational supportpartnership buildingreview and approval