MES Design Specialist

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✍️ Designer

🚫👨‍🎓 No degree required

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Provide flex coverage and independent review capacity across both workstreams • Independently advance mid-complexity PIs when Lead Designers are at capacity • Perform segregation-of-duties reviews of Design Review Checklists • Identify design errors, master-data gaps, and test-case coverage issues • Design PIs, build Test-PIs, develop sMBRs, and create MES master data • Build Test-PIs aligned to Use Cases and sBMR templates for Sub-PI testing • Review design decisions for completeness and technical correctness • Manage validation forms and incident tracking in Kneat or an equivalent system • Create specification files and manage documents in Veeva VQD or an equivalent system • Shift between workstreams and operate independently under schedule pressure

🎯 Requirements

• 2+ years of hands-on Siemens OpCenter Execution Pharma configuration experience, including PI design, Test-PI build, sMBR development, and MES master data creation • Experience working in an FDA-regulated pharmaceutical manufacturing environment • Demonstrated understanding of GMP requirements for electronic batch records • Ability to perform independent Design Review Checklist (DRC) reviews for PIs designed by another engineer • Experience building Test-PIs aligned to Use Cases and sBMR templates for Sub-PI testing • Working knowledge of MES master data, including workcenters, equipment instances, classes, properties, statuses, and sMBR structure • Proficiency with Kneat or equivalent electronic validation management system for validation form management and incident tracking • Proficiency with Veeva VQD or equivalent for specification file creation and document management • Ability to operate independently under schedule pressure and shift between workstreams without needing to be re-onboarded to each PI • Preferred: experience on a formal MES implementation program with defined schedules and milestone commitments • Preferred: familiarity with transport request processes and TEST/VAL/PROD environment management • Preferred: conceptual exposure to SAP-to-MES or OSI-PI-to-MES interfaces • Preferred: prior flex or cross-workstream experience on a multi-team implementation • Preferred: experience supporting engineering or E2E water runs in a pharmaceutical MES environment • Required hands-on proficiency with Siemens OpCenter Execution Pharma, Kneat, and Veeva VQD

🏖️ Benefits

• 1099/W2 engagement options • Remote work