Lead MES Designer - 1099/W2

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