Lead MES Designer

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the complete design lifecycle for the designated workstream.

• Transform BPM/BPD inputs into thoroughly validated, production-ready PIs.

• Design MES processes.

• Configure PIs within Siemens OpCenter.

• Lead show-and-tell sessions.

• Create and implement Design Review Checklists (DRCs).

• Develop Test-PIs and sMBRs.

• Generate and oversee master data.

• Assist in testing and validation to ensure PROD readiness.

• Justify design choices to Process Owners, QA, and Operations.

• Coordinate transport execution across TEST, VAL, and PROD MES environments with COE or IT teams.

• Create and maintain MES Specification Files using Veeva VQD.

• Author validation protocols and handle incidents using Kneat.

⛳️ Requirements

• Minimum of 3 years of practical experience in Siemens OpCenter Execution Pharma (SIMATIC IT) configuration, encompassing PI design, recipe/phase logic, sMBR development, and master data management.

• Proven experience in designing and validating eBR/MES PIs in an FDA-regulated pharmaceutical or biopharmaceutical setting.

• Demonstrated experience in authoring and executing Design Review Checklists (DRCs) and Validation Forms for MES PIs within a GMP framework.

• Experience in constructing Test-PIs and master sBRs (sMBRs) aligned with BPM/BPD Use Cases and production demands.

• Knowledge of MES master data structures, including workcenters, equipment instances, classes, properties, statuses, and their connections to SAP and OSI-PI interfaces.

• Familiarity with managing transport requests across TEST, VAL, and PROD MES environments, including collaboration with a COE or IT team for transport execution.

• Direct experience with GSK-provided or equivalent Business Process Maps (BPMs) and Business Process Detail documents (BPDs) as key design inputs.

• Capability to engage in and facilitate show-and-tell sessions with cross-functional stakeholders, incorporating feedback into iterative design improvements.

• Proficient in Kneat or a similar electronic validation management system for validation protocol creation and incident management.

• Skilled in using Veeva VQD or a comparable tool for MES Specification File creation and oversight.

• Preferred: Experience in Weigh & Dispense PI design or scale integration within a pharma MES context.

• Preferred: Background on a multi-workstream, parallel MES implementation with structured project schedules and milestone commitments.

• Preferred: Understanding of SAP-to-MES and OSI-PI-to-MES interfaces in a pharmaceutical production context.

• Preferred: Experience executing formal E2E water runs and engineering runs in TEST and/or PROD MES environments.

• Preferred: Previous experience with GSK, Pfizer, Lilly, Novartis, AstraZeneca, or other large pharmaceutical MES settings.

🏝️ Benefits

• Options for 1099/W2 engagement.

• Remote work opportunity.

• Full-time employment.