MES Design Specialist

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

📋 Description

• Provide flexible coverage and independent review capabilities across various workstreams.

• Independently progress mid-complexity PIs when Lead Designers are at capacity.

• Conduct segregation-of-duties reviews of Design Review Checklists.

• Detect design errors, gaps in master data, and issues with test-case coverage.

• Design PIs, create Test-PIs, develop sMBRs, and generate MES master data.

• Develop Test-PIs that are aligned with Use Cases and sBMR templates for Sub-PI testing.

• Evaluate design decisions for completeness and technical accuracy.

• Oversee validation forms and incident tracking in Kneat or a similar system.

• Produce specification files and manage documents using Veeva VQD or an equivalent platform.

• Transition between workstreams and operate independently under scheduling pressures.

⛳️ Requirements

• A minimum of 2 years of practical experience with Siemens OpCenter Execution Pharma configuration, including PI design, Test-PI creation, sMBR development, and MES master data generation.

• Experience in an FDA-regulated pharmaceutical manufacturing setting.

• Proven understanding of GMP requirements concerning electronic batch records.

• Capability to perform independent Design Review Checklist (DRC) evaluations for PIs designed by other engineers.

• Experience in building Test-PIs that align with Use Cases and sBMR templates for Sub-PI testing.

• Familiarity with MES master data, encompassing workcenters, equipment instances, classes, properties, statuses, and sMBR structure.

• Proficiency in Kneat or a comparable electronic validation management system for managing validation forms and incident tracking.

• Proficiency in Veeva VQD or a similar system for creating specification files and managing documents.

• Ability to work independently under schedule pressure and shift among workstreams without the need for re-onboarding to each PI.

• Preferred: experience in a structured MES implementation program with defined schedules and milestone commitments.

• Preferred: knowledge of transport request processes and management of TEST/VAL/PROD environments.

• Preferred: conceptual understanding of SAP-to-MES or OSI-PI-to-MES interfaces.

• Preferred: previous flex or cross-workstream experience in a multi-team implementation.

• Preferred: experience in supporting engineering or E2E water runs within a pharmaceutical MES environment.

• Required hands-on proficiency with Siemens OpCenter Execution Pharma, Kneat, and Veeva VQD.

🏝️ Benefits

• Options for 1099/W2 engagement.

• Opportunity for remote work.