MES Design Specialist - 1099/W2

GMP Pros · United States · posted today ago

Listing supplied by Himalayas. 101 Careers did not originate this post and applications are handled by the employer.

About this role

The MES Design Specialist provides flex coverage and independent review capacity across both workstreams. This role is not a junior support role — it requires genuine OpCenter hands-on capability, because this person may be handed a mid-complexity PI and expected to move it forward independently when one of the Lead Designers is at capacity. The Specialist also serves as the segregation-of-duties reviewer for Design Review Checklists, which means they must be competent enough to identify design errors, gaps in master data, and test case coverage issues without guidance. Think of this as a third designer with a broader mandate rather than a specific workstream.

Required Qualifications

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 with demonstrated understanding of GMP requirements for electronic batch records
Ability to perform independent DRC review (Design Review Checklist execution) for PIs designed by another engineer — this requires the ability to critically evaluate design decisions, not just check formatting
Experience building Test-PIs aligned to Use Cases and sBMR templates for Sub-PI testing
Working knowledge of MES master data: 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 fluidly without needing to be re-onboarded to each PI

Preferred Qualifications

Experience on a formal MES implementation program with a defined schedule and milestone commitments (not just maintenance or support work)
Familiarity with transport request process and TEST/VAL/PROD environment management
Exposure to SAP-to-MES or OSI-PI-to-MES interfaces at a conceptual level
Prior experience functioning in a flex or cross-workstream capacity on a multi-team implementation
Experience supporting engineering or E2E water runs in a pharmaceutical MES environment