About Allogene:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
The Senior Engineer will support Allogene’s manufacturing facility in Newark, CA and Allogene’s headquarters facility in South San Francisco, CA. The Senior Engineer will be responsible for supporting utilities, plant, equipment, and leading sustained operations. The Senior Engineer will provide system ownership, resolution of issues, and manage projects associated with the growth and sustained functionality of the sites.
Responsibilities include, but are not limited to:
- Provide technical support of equipment, facilities and utilities throughout the plant including temperature-controlled units, lab and benchtop equipment, autoclave, parts washer, and utilities (HVAC, chilled/hot water, process gases)
- Serve as system owner/engineer for the building utilities, facility and/or equipment
- Create, review, approve and own system lifecycle documents including commissioning and qualification, SOPs, drawings, TOPs and change control.
- Ensure effective operation of system by monitoring, troubleshooting, and maintaining system in a reliable, compliant state as evidenced by measurements
- Lead the implementation of engineering solutions based on your previous cGMP experience
- Support and/or lead utilities and supporting equipment specification, troubleshooting and lifecycle management
- Provides leadership and direction to operations colleagues and contractors
- Support and/or lead creation and implementation of engineering policies
- Support the creation of SOP’s and other compliance related documentation as appropriate
- Support/lead commissioning and qualification requirements and documentation
- Support/lead compliance requirements such as change control, deviations and CAPA’s
- Support the utilities infrastructure programs including maintenance needs assessment, and defining optimization opportunities, calibration and maintenance requirements
- Lead the implementation and execution of project management activities, based on your previous cGMP experience
- Lead small, medium and/or large sized projects as assigned/required
- Support engineering project management policies and programs
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree in an Engineering or Scientific discipline, or related experience
- 8+ years of relevant industry experience and practical experience with plant engineering or operations is preferred
- Prior experience with PPQ runs, BLA submissions, and PAI support is preferred
- Working knowledge of instrumentation and calibration, GMP, change control and qualification related to equipment/utilities
- Demonstrated ability to develop requirements, scope, budget, timelines and manage engineering projects
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
Physical Demands / Surroundings:
- Frequent use of a computer monitor, keyboard and mouse required
- Frequent lifting, carrying, pushing or pulling up to 20 pounds required
- Frequent periods of sitting, walking, and standing required
- Frequent use of personal protective equipment required
- Occasional climbing stairs or ladders, bending or stooping, crouching or squatting required
- Occasional fine finger dexterity/ including grasping or pinching required
- Occasional work in cold rooms and freezers required
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $135,000 to $160,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
