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BlackStar

Senior MES Engineer (Life Sciences)

BlackStar, Raleigh, North Carolina, United States, 27601

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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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