Associate Staff Engineer,Siemens OpCenter

Tasks

• Analyze business process flows into MES recipes and workflows
• Collaborate with business and manufacturing teams for process alignment and compliance
• Conduct requirement workshops and convert into functional and technical MES designs
• Design recipes operations and unit procedures aligned with S88 and MBR
• Drive EBR design configuration and validation
• Drive continuous improvement and innovation within MES MOM landscape
• Ensure GxP 21 CFR Part 11 compliance and CSV validation
• Identify and manage quality and manufacturing risks during MES implementation
• Integrate MES with upstream and downstream systems
• Lead Siemens OpCenter MES solution design and implementation
• Provide technical leadership mentoring and governance for MES projects
• Support UAT system validation and production deployment

Perks/Benefits

• N/A

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | Batch Process | Batch Record | Batch process modeling | Batch records | Biotechnology Manufacturing | CFR Part 11 | CSV | Computer system | Computer system validation | EBR | Electronic batch records | GxP | ISA S88 | Manufacturing Batch Record | Manufacturing execution | MoM | Opcenter MES | Operations | Part 11 | Pharmaceutical manufacturing | Process Development | Process Modeling | Recipe authoring | SDLC | Siemens OpCenter Pharma | Siemens Opcenter | Siemens Opcenter MES | System validation | UAT | Unit Procedures