MES Opcenter Pharma Engineer (m/f/d)

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