This role requires a Siemens OpCenter practitioner who can take a BPM/BPD and turn it into a fully validated, production-ready PI. The Lead Designer owns the end-to-end design lifecycle for their assigned workstream: blueprinting, PI configuration in OpCenter, show-and-tell facilitation, Design Review Checklist (DRC) authorship and execution, Test-PI and sMBR development, master data creation, and testing/validation support through to PROD readiness. This is not a staffing role where someone follows a script — GSK will be actively reviewing design decisions and the Lead Designer must be able to defend them in a room with Process Owners, QA, and Operations.
Required Qualifications
- 3+ years of hands-on Siemens OpCenter Execution Pharma (SIMATIC IT) configuration experience — including PI design, recipe/phase logic, sMBR development, and master data management
- Direct experience designing and validating eBR/MES PIs in an FDA-regulated pharmaceutical or biopharmaceutical environment
- Experience authoring and executing Design Review Checklists (DRCs) and Validation Forms for MES PIs in a GMP context
- Experience building Test-PIs and master sBRs (sMBRs) aligned to BPM/BPD Use Cases and production requirements
- Working knowledge of MES master data structures: workcenters, equipment instances, classes, properties, statuses, and their relationships to SAP and OSI-PI interfaces
- Familiarity with transport request management across TEST, VAL, and PROD MES environments — including coordination with a COE or IT team for transport execution
- Experience working directly with GSK-provided or equivalent Business Process Maps (BPMs) and Business Process Detail documents (BPDs) as primary design inputs
- Ability to participate in and facilitate show-and-tell sessions with cross-functional stakeholders and incorporate feedback into iterative design
- Proficiency with Kneat or equivalent electronic validation management system for validation protocol authorship and incident management
- Proficiency with Veeva VQD or equivalent for MES Specification File creation and management
Preferred Qualifications
- Experience with Weigh & Dispense PI design or scale integration in a pharma MES context (relevant to this engagement's custom Sub-PI requirement)
- Experience on a multi-workstream, parallel MES implementation with a formal project schedule and milestone commitments
- Familiarity with SAP-to-MES and OSI-PI-to-MES interfaces in a pharma production environment
- Experience executing formal E2E water runs and engineering runs in a TEST and/or PROD MES environment
- Prior GSK, Pfizer, Lilly, Novartis, AstraZeneca, or other large pharma MES experience
Key Tools & Platforms
Siemens OpCenter Execution Pharma (required, hands-on) | Kneat (required) | Veeva VQD (required) | SAP (awareness) | OSI-PI / PI System (awareness) | MS Project (awareness) | Microsoft Teams / SharePoint
Skills Required
- 3+ years of hands-on Siemens OpCenter Execution Pharma (SIMATIC IT) configuration experience, including PI design, recipe and phase logic, sMBR development, and master data management
- Direct experience designing and validating eBR/MES PIs in an FDA-regulated pharmaceutical or biopharmaceutical environment
- Experience authoring and executing Design Review Checklists and Validation Forms for MES PIs in a GMP context
- Experience building Test-PIs and master sBRs aligned to BPM/BPD use cases and production requirements
- Working knowledge of MES master data structures and SAP and OSI-PI interfaces
- Familiarity with transport request management across TEST, VAL, and PROD MES environments
- Experience working with Business Process Maps and Business Process Detail documents as primary design inputs
- Ability to participate in and facilitate show-and-tell sessions with cross-functional stakeholders
- Proficiency with Kneat or an equivalent electronic validation management system
- Proficiency with Veeva VQD or an equivalent system for MES Specification File creation and management
- Experience with Weigh and Dispense PI design or scale integration in a pharma MES context
- Experience on a multi-workstream, parallel MES implementation with formal project schedules and milestones
- Familiarity with SAP-to-MES and OSI-PI-to-MES interfaces in a pharma production environment
- Experience executing formal end-to-end water runs and engineering runs in TEST or PROD MES environments
- Prior experience with GSK, Pfizer, Lilly, Novartis, AstraZeneca, or other large pharmaceutical companies
What We Do
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