Our client is an innovative, clinical-stage biotechnology company advancing next-generation cell therapies for cancer and autoimmune diseases. They are seeking an experienced Senior Engineer to support facility operations, utilities, and equipment across two Bay Area locations.
This is an exciting opportunity to take ownership of critical facility systems, lead engineering projects, and help maintain reliable, compliant operations in a cGMP-regulated environment.
Key Responsibilities
- Provide technical support for facility equipment and utilities, including HVAC, temperature-controlled units, autoclaves, process gases, and chilled/hot water systems.
- Serve as the system owner for assigned utilities, facilities, and equipment, ensuring reliable performance and regulatory compliance.
- Lead troubleshooting, equipment lifecycle management, and engineering improvements.
- Develop and maintain technical documentation, including SOPs, commissioning and qualification documents, drawings, and change controls.
- Support cGMP compliance activities, including deviations, CAPAs, calibration, maintenance, and qualification.
- Lead engineering projects from planning and budgeting through execution, ensuring timelines and requirements are met.
- Provide technical guidance to operations teams and contractors while identifying opportunities to optimize facility systems.
Qualifications
- Bachelor’s degree in Engineering, a scientific discipline, or equivalent relevant experience.
- 8+ years of relevant industry experience, preferably in plant engineering or operations.
- Working knowledge of cGMP requirements, instrumentation, calibration, change control, and equipment/utilities qualification.
- Experience defining project scope, budgets, timelines, and technical requirements.
- Strong organizational, communication, problem-solving, and project management skills.
- Experience supporting PPQ runs, BLA submissions, and Pre-Approval Inspections (PAIs) is preferred.
- Must be authorized to work in the United States.
Physical Requirements
- Ability to lift, carry, push, or pull up to 20 pounds.
- Comfortable with frequent sitting, standing, walking, and use of personal protective equipment.
- Ability to occasionally climb stairs or ladders, bend, stoop, and work in cold rooms or freezers.