Electrical Engineer as Compliance Engineer (m / f / d)

BioNTech SE; Mainz; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical industry is seeking a (Senior) Engineer ERP Compliance in Mainz, Germany. This role is crucial for ensuring that ERP systems comply with regulatory frameworks, including GxP and SOX. The successful candidate will manage compliance activities, deviations, and CAPAs, while collaborating with various stakeholders to maintain the validated state of ERP applications. Ideal candidates will have over 5 years of experience in compliance within regulated industries and possess strong analytical and documentation skills.

Leistungen

Flexible working hours

Inclusive culture

Health and lifestyle perks

Employer-funded pension

Childcare support

Qualifikationen

• Over 5 years of professional experience in compliance.
• Proven track record in regulated industries like pharma or MedTech.
• Fluency in English; German preferred.

Aufgaben

• Ensure compliance of ERP applications with GxP, SOX, and GDPR.
• Manage ERP-related deviations and CAPAs.
• Support computer system validation efforts.

Kenntnisse

Compliance Management

Documentation Skills

Analytical Skills

Stakeholder Management

Communication

Ausbildung

Relevant higher education

Tools

SAP

Jobbeschreibung

(Senior) Engineer ERP Compliance - SOX / CAPA

Mainz, Germany | Full-time | Job ID: 9065

The (Senior) Engineer ERP Compliance is responsible for ensuring that all ERP systems within 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. This role plays a critical part in maintaining the validated state of ERP applications, focusing on deviation and CAPA management, as well as contributing to established SOX controls. It encompasses all compliance activities such as validation, change control, and periodic review. Your responsibilities include:

• Ensuring continuous compliance of ERP applications with GxP, SOX, and GDPR requirements.
• Managing ERP-related deviations and non-conformances, including investigation, impact assessment, root cause analysis, and timely resolution in line with quality system expectations.
• Driving effective and sustainable Corrective and Preventive Actions (CAPAs), collaborating closely with IT, QA, and business stakeholders to implement remediation and preventive measures.
• Maintaining documentation and tracking of deviation and CAPA statuses, providing trend analysis and periodic reports to compliance leadership.
• Collaborating with the SOX team and control owners to monitor and test IT general controls (ITGCs) and application-level controls, ensuring compliance with financial reporting obligations, and contributing to SOX control improvements.
• Supporting computer system validation (CSV) efforts for projects and operations, working with CSV teams, functional experts, and QA.
• Supporting change management activities for ERP systems, ensuring impact assessments are conducted and changes are implemented according to validated system procedures.
• Acting as an ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections.

Qualifications and Experience:

• Relevant higher education and over 5 years of professional experience.
• Proven track record in compliance topics within regulated industries (e.g., pharma, chemical, MedTech).
• Experience with GxP regulations, with expertise in deviation/CAPA management and SOX being a plus.
• Understanding of SAP or other ERP-related applications is preferred.
• Well-organized with excellent documentation and analytical skills, capable of synthesizing complex information into clear, actionable insights.
• Ability to quickly familiarize with various technical or regulatory topics, with attention to detail and a quality-first mindset.
• Strong communication and stakeholder management skills, confident in interactions with business stakeholders, auditors, and cross-functional teams.
• Fluency in English; German language skills are preferred.

Benefits:

• Flexible working hours and vacation policies.
• Inclusive culture with opportunities to influence and shape processes, support for your full potential.
• Health and lifestyle perks, such as a company bike.
• Support for different life phases, including employer-funded pension and childcare.