Lead MES Designer - 1099/W2 at Gmppros

Job description

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

Requirements

Must-haves

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
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

Nice-to-haves

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

Application prep

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Platform: bamboohr
Effort: medium