Company Description

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Job Description

Purpose of the Role:
Serve as the primary contact between production/operations and IT for the Manufacturing Execution System (MES), ensuring stable daily operation, effective use by end users, and continuous improvement of system-supported processes.

• Independently develop end-to-end, highly integrated IT processes to comprehensively improve business operations while ensuring cross-plant standardization, including performing a gatekeeper function.
• Take a leading role in the implementation, configuration, and support of IT applications in the relevant functional area (especially ERP/MES, RPA, etc.).
• Actively and continuously analyze end-to-end business processes and identify optimization potential through appropriate IT solutions (e.g., SAP, Industry 4.0 applications).
• Independently plan and implement organizational system adjustments in close cooperation with the specialist departments and central IT departments.
• Independently execute necessary adjustments (customizing and migrations) during live operation, ensuring maximum cross-plant synergies and compliance with the medical industry’s validation and documentation requirements.
• Assume the role of key user/process expert within project teams, actively managing local IT projects and changes.
• Independently plan and conduct employee training sessions and workshops, and advise users on IT-related problems to maximize the utilization and efficiency of IT systems.
• Gatekeeper Function: Serve as the interface to central IT departments; align local IT initiatives with division-wide IT standards and applications; coordinate and request developments/customizing in central IT systems via defined platforms (e.g., Change Advisory Board).

Functional KPIs

• Ensure reliable operation of implemented IT systems.
• Achieve defined project goals in the role of Change Owner/Project Manager.
• Ensure timely implementation of corrective or improvement measures in IT systems.

Qualifications

• Degree or strong experience in engineering, life sciences, or a related technical discipline, preferably within medical device or other FDA‑regulated manufacturing.

• Solid hands‑on experience in device manufacturing operations, process engineering, or quality, with very good understanding of GMP, ISO 13485, and device history / batch documentation.

• Practical experience with an MES or EBR platform in a regulated environment, including working with electronic records, audit trails, and e‑signatures.

• Good understanding of 21 CFR Part 11 concepts (electronic records, electronic signatures, audit trail, access control) and how they apply to MES.

• Strong communication and training skills, able to work cross‑functionally with production, QA/RA, engineering, and IT.

• Structured, detail‑oriented, and comfortable with documentation, validation evidence, and supporting audits.

Additional Information

Why Join Us:

• Be part of a company that values your skills and ideas
• Work in an environment where quality truly matters
• Join a team that supports each other and grows together
• Contribute to products that have global impact

Join us and be part of a forward-thinking team dedicated to innovation and excellence. Together, we will drive digital transformation and achieve remarkable results.