Responsibilities
- Architect and implement full-scale MES solutions (PAS-X Sepasoft POMS etc.) for Life Science manufacturing environments
- Lead project teams in developing system architecture technical specifications and execution plans
- Manage MES integration with systems such as DeltaV SAP LIMS PI Maximo and others
- Ensure compliance with GMP 21 CFR Part 11 GAMP5 and other regulatory requirements
- Act as the technical lead or project manager for medium to large projects ($1M)
- Mentor and support junior engineers and technicians
- Engage in business development including client relations and attending trade shows
- Lay the foundation for a new MES team/office in NC
Qualifications
- Reside in North Carolina
- 10 years of MES engineering experience
- 4 years of MES experience in the Life Sciences industry
- Proven experience with Werum PAS-X Sepasoft or POMS
- Hands-on knowledge of GMP 21 CFR Part 11 GAMP5 ISA-95 ISA-88
- Full lifecycle experience: requirements design implementation testing commissioning
- Experience integrating MES with controls historians ERP and relational databases
- Strong leadership skills with experience guiding multi-disciplinary teams
- Willingness to travel up to 25%
Apply now and take the next step in your engineering leadership journey.