MES / Manufacturing Systems SME

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

MES / Manufacturing Systems SME — East Coast (Greenfield Pharma/Biotech Program)

Business Justification

• Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems.

Position Overview

• Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems. This is an owner-side, program-focused role requiring coordination across multiple stakeholders, suppliers, and delivery teams rather than a narrowly scoped execution-only assignment.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• Experience on a greenfield or major capital pharmaceutical manufacturing program.
• Demonstrated success operating in an owner-side, EPCM, governance, or provider-oversight model.