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Senior MES Engineer - Life Sciences

icon building Company : Blackstar
icon briefcase Job Type : Full Time

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Job Description - Senior MES Engineer - Life Sciences

The company is seeking a Senior MES Engineer to join our growing Life Sciences team in North Carolina. This is a leadership role where you'll serve as both a Solution Architect and Technical Lead, guiding teams in delivering world-class MES (Manufacturing Execution System) solutions for pharmaceutical and biotech clients.

Key Responsibilities:

  • Architect, configure, test, and commission MES solutions in regulated Life Sciences environments
  • Deliver end-to-end MES projects: conceptual design, implementation, validation, start-up, and commissioning
  • Develop strategies that reduce downtime, increase compliance, and improve efficiency
  • Lead and mentor engineers/technicians, providing technical oversight and guidance
  • Support business development by engaging with clients, presenting at conferences, and building long-term relationships
  • Manage project execution plans, budgets, and schedules, and ensure overall project profitability

Must-Have Qualifications:

  • Bachelor's degree in Engineering, Computer Science, or Applied Sciences
  • 10+ years of MES experience; minimum 4 years in Life Sciences MES
  • Proven expertise in deploying Werum PAS-X, Sepasoft, or POMS
  • Strong knowledge of cGMP, 21 CFR Part 11, S88, S95, GAMP5
  • Hands-on experience with EBR recipe design, warehouse & inventory management, and regulatory compliance
  • Skilled in integrating MES with external systems (DeltaV, SAP, LIMS, PI, Maximo)
  • Experience with SQL/Oracle databases, historian technologies, and IT/OT networking
  • Excellent leadership, communication, and technical writing skills
  • Proven ability to bring in new business and represent at trade shows/industry events
  • Must be located in North Carolina and open to 25% travel

Apply today to lead MES innovation in Life Sciences with one of the most respected employee-owned engineering firms in the U.S.

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