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MES Program Manager

Radiant System, IncLexington, MA🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationLexington, MA, United States
ConfluenceWaterfallJiraAgile

Job description

Seeking an experienced MES Program/Portfolio Manager to manage multiple concurrent Manufacturing Execution System (MES) projects in a GMP-regulated biologics manufacturing environment. Responsible for tracking project milestones, Change Controls, CAPAs, risks, and cross-project dependencies while coordinating with internal teams and external vendors.

Required Skills:

  • 5+ years of digital project/program management experience in a GMP environment.

  • 3+ years of MES experience; PAS-X preferred.

  • Direct experience with biologics manufacturing processes and equipment.

  • Knowledge of ISA-95 and ISA-88 standards.

  • Experience with MES integration involving ERP, Automation, and Lab Systems.

  • Strong knowledge of Agile and Waterfall methodologies.

  • Experience managing multiple projects, risks, dependencies, and stakeholders.

  • Ability to work independently in a complex matrix environment.

Preferred Skills:

  • Werum PAS-X MES experience.

  • TrackWise, Veeva, or similar quality management systems.

  • JIRA and Confluence.

  • Knowledge of GMP manufacturing automation systems.

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