MES/SAP Specialist

Get AI-powered advice on this job and more exclusive features. Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. The plays a key role in supporting, enhancing, and integrating Manufacturing Execution Systems (MES) and SAP ERP systems within a regulated pharmaceutical manufacturing environment. This position ensures seamless digital data flow from planning to production, maintaining compliance with GxP, FDA 21 CFR Part 11, and other regulatory standards. We are considering candidates across Europe. The ideal candidate is comfortable working remotely, and is also willing to travel to customer sites within the EU when required — depending on project phase and on-site activity needs. Responsibilities Administer, configure, and maintain MES (e.g., Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter) and SAP PP-PI modules. Troubleshoot system issues, coordinate resolution with IT, automation, and production teams. Manage and support MES–SAP interfaces for master data, batch records, material movement, and production orders. Ensure accurate synchronization of production data between MES and SAP for materials, BOMs, and process orders. Participate in or lead MES/SAP implementation, upgrade, and validation projects. Gather user requirements, translate them into functional/technical specifications, and coordinate with vendors or developers. Prepare and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ) following GAMP5 principles. Ensure systems operate in compliance with GMP, GDP, and data integrity standards. Provide first-line user support and conduct MES/SAP user training sessions. Develop and update user manuals, SOPs, and training materials. Identify opportunities for system and process optimization in digital manufacturing. Support the transition toward paperless batch records and Industry 4.0 initiatives. Requirements Bachelor’s degree in Computer Science, Information Technology, Engineering, or Life Sciences. min. 3 years of experience in MES and/or SAP systems in the pharmaceutical, biotech, or life sciences industry. Hands‑on experience with MES (Werum PAS-X, Rockwell PharmaSuite, or equivalent) and SAP PP-PI/MM/QM modules. Experience in GxP-regulated environments with knowledge of FDA 21 CFR Part 11 and Annex 11 compliance. Knowledge of SQL, XML, interfaces, and data mapping. Understanding of manufacturing workflows, batch management, and electronic batch records (eBR). Familiarity with system validation and documentation standards (CSV, GAMP5). Strong analytical, problem‑solving, and communication skills. Proficiency in English Proficiency in German (nice to have) Ability to work cross-functionally with IT, QA, Production, and Engineering teams. Attention to detail and a proactive approach to system reliability and compliance. Contract Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us. Seniority level Mid‑Senior level Employment type Other Job function Consulting Pharmaceutical Manufacturing and Medical Equipment Manufacturing Referrals increase your chances of interviewing at PQE Group by 2x Get notified about new SAP Specialist jobs in European Union . #J-18808-Ljbffr