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