Principal Plant Engineer - HVAC, CVRM

About the role

Roche/Genentech is building a $2 billion greenfield plant in Holly Springs, North Carolina, dedicated to manufacturing cardiovascular, renal and metabolism (CVRM) medicines. As Principal Plant Engineer, you will be the site's highest-level technical subject matter expert for the HVAC/R program, covering end-to-end asset management of HVAC, refrigeration, cold/warm room systems and plant utilities. The plant is planned to launch in 2028.

Key responsibilities

• Pre-startup: join the user team and establish the site's foundational asset management program for HVAC-R and plant utilities, partnering with Engineering, Quality, Supply Chain, Regulatory, CMO and other groups on project management, technical design, testing, qualification and validation of air handling units, chillers, cooling towers, hot water units and cold rooms.
• Transition to full-time on-site work once buildings are built and equipment delivered, with up to 30% travel during the project phase.
• Post-startup: lead the facility's HVAC systems to maximum reliability and cGMP compliance, and contribute to master data and maintenance programs in SAP S4/HANA.
• Oversee HVAC/R and cleanroom performance testing contracts, troubleshoot in the field, run root cause analysis and own deviations, change controls and CAPAs, working with Automation, Validation, Calibration, Quality and Manufacturing.
• Own utility, HVAC/R, electrical and control systems, ensuring continuous compliance and audit readiness.
• Develop and optimize a reliability program, manage instrumentation and equipment obsolescence, and champion continuous improvement to reduce downtime.
• Ensure utility systems are compliant from a regulatory standpoint, provide audit support, develop and own the HEPA program, and act as point of contact for HVAC-related QMS records (change controls, deviations).
• Comply with EPA Section 608 as applicable, train new hires, coach colleagues, and influence stakeholders across the organization.

Required profile

• Bachelor's degree in engineering or life sciences with 8+ years of experience in the pharmaceutical or related industry in a cGMP environment, or an associate's degree with 10+ years of such experience.
• Updated knowledge of cGMP, health authority regulations and quality systems.
• Experience collaborating with regulators, agencies and vendors, and advising senior management on technical matters.
• Strong organizational and interpersonal skills, coaching others.
• Ability to work in an international environment, with domestic and international travel (up to 20% after startup); potential to work in a clean room and near hazardous materials, and flexibility for overtime and schedule changes.
• Relocation assistance is not available.

Required skills

• Process control and building automation systems.
• Preferred: propane, CO2 and ammonia systems, fire suppression and monitoring systems, and thorough understanding of electrical systems.

Expected salary range for Holly Springs: $95,200 - $176,800, depending on experience and qualifications; a discretionary annual bonus may be available.