Senior/Principal Clean Utilities Specialist - CVRM Facility

About the role

Roche and Genentech are building a new greenfield biomanufacturing facility in Holly Springs, North Carolina, for its Cardiovascular, Renal and Metabolic (CVRM) mission. The role sits in Facilities & Engineering and is accountable for the integrity, reliability and compliance of clean utility systems, from pre-start-up planning through post-start-up maintenance of GMP assets.

Key responsibilities

• Pre-start-up: act as user team representative, set up the maintenance program (procedures, training, spare parts strategy, master data, maintenance plans), support FATs and SATs, and provide technical support through design review, installation, commissioning, qualification and turnover.
• Post-start-up: carry out planned preventative maintenance and repairs, troubleshoot PLC/automation, and adhere to SOPs, cGMP and safety standards.
• Maintain and repair utilities, electrical and HVAC systems such as water-for-injection, chilled water, clean steam, cold rooms, cooling towers and fire protection.
• Create and run continuing education for maintenance staff, and help identify spare parts and BOM improvements.
• Provide inputs to master data in SAP S4/HANA, support Quality Record management, and maintain audit readiness.
• Oversee external service providers, manage changes, handle deviations and root cause analysis, and act as first responder to facility alarms.

Required profile

• Senior level: high school diploma or equivalent with 10+ years of industrial/manufacturing experience, or a trade certificate with 8+ years; Principal level: 14+ years or a trade certificate with 12+ years.
• Strong mechanical aptitude and hands-on background in maintenance, equipment installation, instrument calibration or programming.
• Familiarity with cGMP, health authority regulations and quality systems.
• Ability to read mechanical drawings, electrical schematics, hydraulic/pneumatic diagrams and P&IDs.
• Shift work with possible overtime or on-call duty; potential to work in a clean room and near hazardous materials.

Required skills

• Utility, HVAC and electrical systems in regulated environments
• Building Management Systems, Computerized Maintenance Management Systems and predictive maintenance
• SAP S4/HANA and Quality Management Systems
• AI and digital tools, technical writing and project management