GMP Utility Engineer - Biopharma Process Systems Lead

SGS Consulting; Sacramento (CA); On-site; USD 85,000 - 140,000; Full time

Job summary

SGS Consulting is seeking an experienced Utilities/Process Engineer to optimize and support critical utility systems in a GMP manufacturing setting. You will analyze performance, lead project lifecycles, and drive improvements across water systems, steam, and related infrastructure.

You will collaborate with Manufacturing, Quality, Facilities, and Global Engineering to ensure regulatory compliance, develop documentation, and sustain safe, reliable operations.

Qualifications

• Bachelor's degree in an engineering discipline.
• 3–8+ years in utilities or process engineering in GMP manufacturing.
• Experience with water systems, clean steam, compressed gases, and process utility infrastructure preferred.
• Experience with GMP/regulatory environments and related documentation.

Responsibilities

• Identify, analyze, and implement improvements for utility, facility, and process systems.
• Provide technical support for utility systems including WFI, WRO, clean steam, water pretreatment, and distribution systems.
• Monitor utility system performance and troubleshoot equipment or process issues.
• Ensure uninterrupted utility supply to support manufacturing operations.
• Lead or support engineering projects through design, construction, commissioning, validation, and project close-out.
• Develop and review project documentation including URS, RFQs, specifications, PFDs, P&IDs, FAT/SAT/IQ protocols, and contractor packages.
• Support deviations, investigations, CAPAs, and audit readiness activities.
• Ensure utility systems comply with FDA, EMA, and other regulatory requirements.
• Perform root cause analysis and implement corrective and preventive actions.
• Collaborate with Manufacturing, Quality, Maintenance, Facilities, and Global Engineering teams.
• Provide technical guidance to utility operators and maintenance personnel.
• Drive continuous improvement initiatives to optimize system performance and engineering standards.

Skills

Utility systems engineering

Process engineering

Engineering project lifecycle

Regulatory compliance

Engineering documentation

Root cause & CAPA

Validation & commissioning

Instrumentation standards

Troubleshooting & optimization

Cross-functional collaboration

Education

Bachelor's degree in Mechanical/Chemical/Electrical/Industrial Engineering

Job description

SGS Consulting is seeking an experienced Utilities/Process Engineer to optimize and support critical utility systems in a GMP manufacturing setting. You will analyze performance, lead project lifecycles, and drive improvements across water systems, steam, and related infrastructure.

You will collaborate with Manufacturing, Quality, Facilities, and Global Engineering to ensure regulatory compliance, develop documentation, and sustain safe, reliable operations.