Senior/Principal Clean Utilities Specialist - CVRM (Holly Springs)
Core
Leading troubleshooting, start-up support, and maintenance of clean utility and plant utility systems (water, steam, HVAC, electrical) in a new biomanufacturing facility.
Role type
Senior/Principal Clean Utilities System Specialist (Facilities & Engineering)
Builds
State-of-the-art greenfield biomanufacturing facility for Cardiovascular, Renal, and Metabolic therapeutics
Domain
Biotechnology / Pharmaceutical Manufacturing / Clean Utilities
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clean utility system operation and maintenance, cGMP compliance, troubleshooting PLC/automation, reading P&IDs and mechanical/electrical schematics, change management, deviation investigation, root cause analysis, spare parts strategy, training and coaching, working in controlled classified environments
Preferred skills
Building Management Systems, Computerized Maintenance Management Systems, predictive maintenance technologies, AI and digital tools for problem solving
Technologies
SAP S4/HANA, PLC/automation systems, Building Management Systems, Computerized Maintenance Management Systems
Responsibilities
Establish maintenance programs and procedures for clean utility systems during pre-startup; execute planned preventative maintenance and repairs on GMP assets post-startup; support FATs and SATs for utility equipment; manage external service providers; initiate deviations and provide root cause analysis; maintain audit-readiness; serve as primary first responder to facility alarms
Seniority
Senior/Principal, hands-on IC with 10-14+ years experience