Senior MES Engineer - Life Sciences
BlackStar
- Raleigh, NC
- $140,000-180,000 per year
- Permanent
- Full-time
- 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
- 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