(Senior) Engineer ERP Compliance - SOX/CAPA
Mainz, Germany | full time | Job ID:9065
The (Senior) Engineer ERP Compliance is responsible to ensure that all ERP systems in scope operate in compliance with relevant regulatory frameworks, including GxP (Good Practice), FDA 21 CFR Part 11, EU GMP Annex 11, and Sarbanes-Oxley (SOX) Section 404. The position plays a critical role in maintaining the validated state of ERP applications focusing on deviation and CAPA management and contribution to established SOX controls. It extends to all compliance activities, such as validation, change control and periodic review. Your responsibilities are:
Ensure continuous compliance of ERP applications with GxP, SOX and GDPR requirements
Manage ERP-related deviations and non-conformances, ensuring investigation, impact assessment, root cause analysis, and timely resolution in line with quality system expectations
Drive effective and sustainable Corrective and Preventive Actions (CAPAs), in close coordination with IT, QA, and business stakeholders to implement remediation and preventive measures
Maintain documentation and tracking of deviation/CAPA status and provide trend analysis and periodic reporting to compliance leadership
Collaborate with the SOX team and SOX control owners to monitor and test SOX ITGCs and application-level controls, ensuring compliance with financial reporting obligations. Contribute to SOX control improvements
Support computer system validation (CSV) efforts for project and run-and-maintain, in collaboration with the CSV team, functional experts and QA
Support change management activities for ERP systems, ensuring that all changes are subject to impact assessment and implemented according to validated system procedures
Act as an ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections. What you have to offer.
Relevant higher education and many years of professional experience (> 5 years)
Proven track record of compliance topics within regulated industries (e.g., pharma, chemical, MedTech).
Experience with GxP regulations, expertise in deviation/CAPA and SOX is a plus.
Understanding of SAP or ERP-related applications preferred
Well-organized with excellent documentation and analytical skills; as well as the ability to synthesize complex information into clear, actionable insights
Ability to familiarize yourself with a variety of different (technical or regulatory) topics, with attention to detail and a quality-first mindset
Strong communication and stakeholder management skills, with the ability to interact confidently with business stakeholders, auditors, and cross-functional teams
Fluency in English, German knowledge is preferred
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