Principal Utilities Engineer
About The Position
Our Oceanside facility is a cutting-edge, multi-product CHO drug substance manufacturing site featuring parallel commercial production and launch capabilities. We are seeking a highly skilled engineer to serve as an Utilities Engineering System Owner. In this role, you will lead engineering support for critical site infrastructure across its full lifecycle—from project design, procurement, and site installation to commissioning, validation, troubleshooting, and continuous improvement. You will collaborate closely with cross-functional teams in Manufacturing, Maintenance, Quality, and Automation to ensure reliable, compliant, and sustainable operations.
Requirements
- Bachelor's degree in Engineering (Mechanical or Chemical Engineering preferred).
- 5–8 years of experience in a corporate or manufacturing engineering environment.
- 5+ years of direct utility engineering experience within biotech, pharmaceutical, or highly regulated cGMP facilities.
- Hands-on knowledge of clean water purification (RO/DI to WFI, Clean Steam) and/or plant mechanical systems (central plant, chillers, boilers, HVAC, compressed air).
- Practical understanding of Building Automation Systems (e.g., Siemens) and skid/PLC control integrations.
- Demonstrated proficiency with cGMP regulations, validation/commissioning protocols, and change control procedures.
- Strong analytical and troubleshooting background using formal RCA/FMEA techniques.
Responsibilities
- Serve as technical lead for the operation, troubleshooting, and continuous improvement of plant mechanical (HVAC, chillers, boilers, natural gas, natural refrigerants) and clean utilities (WFI, clean steam, RO/DI, city/soft water, bulk gases/chemicals).
- Review equipment designs, specifications, P&IDs, and vendor packages. Oversee field installations and commissioning activities while guiding subcontractors and vendors on-site.
- Manage change control processes, author/revise controlled technical documents (SOPs, specifications, validation protocols), and support timely closure of deviations, CAPAs, and audit observations.
- Partner with Process, Automation, Maintenance, and Quality teams to resolve complex technical issues and participate in regulatory audits as a technical Subject Matter Expert (SME).
- Lead root cause analysis (RCA/FMEA) and apply DMAIC/Six Sigma methodologies to drive system reliability, efficiency, and safety.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Qualifies for benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
