Lead MES Designer

Job not on LinkedIn

🕒 September 14

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

✍️ Designer

👻 Ghost score 22%

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GMP Pros, Inc.®

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2013

💼 Consulting

🍽️ Food & Beverage

🏭 Manufacturing

Consulting • Food & Beverage • Manufacturing

GMP Pros, Inc. ® is a professional consulting engineering firm specializing in regulated manufacturing sectors like pharmaceuticals, food, and biologics. The company focuses on optimizing capacity, efficiency, and quality for its clients by providing expert engineering project teams that excel in electronic batch records implementation, production engineering, and data science analytics. With a commitment to regulatory compliance and industry standards, GMP Pros helps manufacturers achieve significant improvements in operational performance and product yield.

📋 Description

• Own the end-to-end design lifecycle for the assigned workstream • Convert BPM/BPD inputs into fully validated, production-ready PIs • Blueprint MES processes • Configure PIs in Siemens OpCenter • Facilitate show-and-tell sessions • Author and execute Design Review Checklists (DRCs) • Develop Test-PIs and sMBRs • Create and manage master data • Support testing and validation through PROD readiness • Defend design decisions with Process Owners, QA, and Operations • Coordinate transport execution across TEST, VAL, and PROD MES environments with COE or IT teams • Create and manage MES Specification Files using Veeva VQD • Author validation protocols and manage incidents using Kneat

🎯 Requirements

• 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: Experience with Weigh & Dispense PI design or scale integration in a pharma MES context • Preferred: Experience on a multi-workstream, parallel MES implementation with formal project schedules and milestone commitments • Preferred: Familiarity with SAP-to-MES and OSI-PI-to-MES interfaces in a pharma production environment • Preferred: Experience executing formal E2E water runs and engineering runs in TEST and/or PROD MES environments • Preferred: Prior experience with GSK, Pfizer, Lilly, Novartis, AstraZeneca, or other large pharma MES environments

🏖️ Benefits

• 1099/W2 engagement options • Remote work • Full-time employment

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