MES Opcenter Pharma Engineer (mfd)
Job Summary
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 thedesign configuration validation and deploymentof Siemens Opcenter Execution Pharmawithin 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
Required Experience:
IC
About Company
As a global automation and technology leader, ATS Corporation supports some of the world’s most successful companies in bringing products to market.