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.
The Opportunity
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.
Key Responsibilities:
System Ownership & Leadership: 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).
Project & Field Execution: Review equipment designs, specifications, P&IDs, and vendor packages. Oversee field installations and commissioning activities while guiding subcontractors and vendors on-site.
cGMP & Quality Compliance: Manage change control processes, author/revise controlled technical documents (SOPs, specifications, validation protocols), and support timely closure of deviations, CAPAs, and audit observations.
Cross-Functional Collaboration: 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).
Operational Excellence & Reliability: Lead root cause analysis (RCA/FMEA) and apply DMAIC/Six Sigma methodologies to drive system reliability, efficiency, and safety.
Who You Are
Education: Bachelor's degree in Engineering (Mechanical or Chemical Engineering preferred).
Experience:
Technical Expertise:
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.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of California is $95,200 - $176,800 annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
