Senior Engineer, Facilities

Allogene Therapeutics•Newark, NJ

5d•Onsite

About The Position

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. 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.

Requirements

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.

Responsibilities

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