Senior MES & Manufacturing Systems SME - Pharma/Biotech

Valspec; Boston (MA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

ESOP

Medical coverage

401(k) with company match

Tuition reimbursement

Performance incentives

Zusammenfassung

Valspec is a global provider of system validation and lifecycle services, calling for an MES / Manufacturing Systems SME for the East Coast (Greenfield Pharma/Biotech Program). You will translate manufacturing and quality requirements into MES, EBR, recipes, workflows, and master data, coordinating across stakeholders to ensure program success.

The role emphasizes owner-side governance, MES design, validation, and deployment, with collaboration across DCS/PLC/SCADA, ERP, LIMS, historians, CMMS,

Qualifikationen

• Bachelor's degree in engineering, computer science, information systems, or related field, or equivalent experience.
• 8+ years of MES or manufacturing systems experience in pharmaceutical or biotech manufacturing.
• Hands-on experience with EBR/MBR design, recipe/workflow configuration, MES validation, and regulated manufacturing processes.
• Experience with one or more enterprise MES platforms and integrations using ISA-88/ISA-95 concepts.

Aufgaben

• Translate manufacturing and quality requirements into MES, EBR, recipe, workflow, and master-data solutions.
• Support MES architecture, design reviews, requirements, configuration oversight, testing, validation, deployment, and stabilization.
• Coordinate interfaces with DCS/PLC/SCADA, ERP, LIMS, historians, CMMS, and data platforms.
• Support business process mapping, electronic record design, exception handling, data integrity, and operational readiness.
• Partner with manufacturing, quality, automation, IT/OT, CSV, and system integrators.

Kenntnisse

MES experience

EBR/MBR design

ISA-88/ISA-95

ERP/MES integration

Ausbildung

Bachelor's degree in engineering or related field

Jobbeschreibung

Valspec is a global provider of system validation and lifecycle services, calling for an MES / Manufacturing Systems SME for the East Coast (Greenfield Pharma/Biotech Program). You will translate manufacturing and quality requirements into MES, EBR, recipes, workflows, and master data, coordinating across stakeholders to ensure program success.

The role emphasizes owner-side governance, MES design, validation, and deployment, with collaboration across DCS/PLC/SCADA, ERP, LIMS, historians, CMMS,