Senior Utilities Engineer (Biotech GMP Plant)

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 95,000 - 177,000; Full time

Job summary

Genentech in California seeks an Utilities Engineering System Owner to lead and optimize plant mechanical and clean utility systems, including HVAC, boilers, and water purification.

The role requires 5–8 years in manufacturing engineering and 5+ years in biotech utility engineering, with strong cGMP, RCA/FMEA, and collaboration across Process, Automation, Maintenance, and Quality teams.

Qualifications

• Bachelor's degree in Engineering (Mechanical or Chemical) required.
• 5–8 years of experience in corporate/manufacturing engineering.
• 5+ years of direct utility engineering experience in biotech/pharma or regulated facilities.
• Hands-on knowledge of clean water purification (RO/DI to WFI, Clean Steam) and plant mechanical systems.
• Experience with Building Automation Systems (e.g., Siemens) and skid/PLC control integrations.
• Proficiency with cGMP regulations, validation/commissioning, and change control.

Responsibilities

• Serve as technical lead for operation, troubleshooting, and continuous improvement of plant mechanical and clean utilities.
• Review equipment designs, specs, P&IDs, and vendor packages; supervise field installations and commissioning on-site.
• Manage change control processes; author/revise SOPs, specifications, validation protocols; support deviations, CAPAs, and audits.
• Partner with Process, Automation, Maintenance, and Quality teams to resolve complex issues and participate in regulatory audits as SME.
• Lead RCA/FMEA and apply DMAIC/Six Sigma to drive reliability, efficiency, and safety.

Skills

HVAC systems

Chillers

Boilers

Natural gas systems

Clean utilities

RCA/FMEA

cGMP compliance

Cross-functional collaboration

Troubleshooting

Education

Bachelor's degree in Mechanical or Chemical Engineering

Tools

Siemens BAS

PLC integration

Job description

Genentech in California seeks an Utilities Engineering System Owner to lead and optimize plant mechanical and clean utility systems, including HVAC, boilers, and water purification.

The role requires 5–8 years in manufacturing engineering and 5+ years in biotech utility engineering, with strong cGMP, RCA/FMEA, and collaboration across Process, Automation, Maintenance, and Quality teams.