Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)
Core
Leading troubleshooting and issue resolution for highly complex mechanical challenges on medical device assembly equipment, while establishing maintenance programs and supporting production at a new manufacturing site.
Role type
Principal Maintenance Specialist (Medical Device Assembly)
Builds
Medical device assembly lines (Component Prep, Liquid PFS Filling, Autoinjector Assembly, Packaging) for Cardiovascular, Renal and Metabolism therapies.
Domain
Pharmaceutical manufacturing / Medical device assembly
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical aptitude, troubleshooting complex mechanical challenges, coaching and mentoring staff, reading P&IDs, understanding cGMP and Quality Management Systems, working in controlled/aseptic environments, identifying spare parts and BOM improvements, using SAP S4/HANA
Preferred skills
A.A./A.S./Trade School Certificate, experience with PLC/automation, familiarity with AI and digital tools, project management
Technologies
SAP S4/HANA, PLC/automation systems
Responsibilities
Establish site maintenance programs and procedures for assembly equipment, perform planned preventative maintenance and repairs on GMP assets, create continuing education and training for maintenance staff, support troubleshooting of PLC/automation, provide SME for Quality Record management, input master data for maintenance programs
Seniority
Principal, hands-on IC with mentorship responsibilities
