To support a large-scale Manufacturing Execution System (MES) transformation program at one of our Customers, we are looking for a Medior to Senior MES Opcenter Pharma Engineer (m/f/d).
You will play a key role in the design, configuration, validation, and deployment of Siemens Opcenter Execution Pharma within a GMP-regulated manufacturing environment. You will work closely with process experts, QA, IT, automation, and business stakeholders to translate manufacturing requirements into compliant and robust MES solutions.
Your responsibilities
MES Design & Implementation
-Design, configure, and implement Siemens Opcenter Execution Pharma solutions aligned with shop-floor manufacturing processes
-Translate User Requirements (URS) into functional and technical MES design
-Configure electronic batch records (EBR), workflows, recipes, material tracking, and equipment modeling
-Support integration with DCS/PLC systems, ERP (e.g. SAP), and other manufacturing systems
Project & Delivery Support
-Participate in full MES project lifecycle: analysis, design, build, testing, deployment, and hypercare
-Contribute to technical discussions with both business and IT stakeholders
-Support system deployment across different manufacturing areas or sites (as applicable)
Validation & Compliance
-Ensure MES solutions comply with GMP, GAMP5, and 21 CFR Part 11 requirements
-Support CSV activities including risk assessments, specifications, test protocols, and deviation handling
-Align with quality standards, SOPs, and validation frameworks
Testing & Go Live
-Prepare and execute FAT/SAT, integration testing, and UAT support
-Support manufacturing during go live and ramp up phases
-Troubleshoot MES-related issues in collaboration with IT, QA, and operations
Collaboration & Knowledge Sharing
-Act as a technical reference within the MES team
-Coach and support more junior MES engineers (senior profiles)
-Document solutions and contribute to standardization and best practices
Your profile
-Sound experience of multiple years working with MES systems in a pharmaceutical or life sciences environment
-Proven hands on experience with Siemens Opcenter Execution Pharma
-Strong understanding of pharma manufacturing processes (batch manufacturing, materials management, equipment modeling)
-Experience with MES integrations (ERP, automation, serialization is a plus)
-Solid understanding of GMP, GAMP 5, and CSV principles
-Familiarity with electronic records, audit trails, and system security concepts
-Strong analytical and problem-solving skills
-Able to communicate clearly with both technical and non technical stakeholders
-Comfortable working in large, structured enterprise programs
-Proactive mindset and ownership mentality
-Business Fluency in English, able to communicate clearly with both technical and non technical stakeholders
-Dutch/Flemish and French business fluency are advantage
Nice to Have / Assets
-Experience working in large pharma programs
-Experience with Siemens Opcenter Execution Core / MBR Designer
-Knowledge of ISA 95 / ISA 88 concepts
-Experience in multi-site MES rollouts
-Previous exposure to DCS/PLC environments
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