Facilities & Engineering | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
About the role:
The Senior Engineer will report to the Director, Facilities and Engineering at Allogene Therapeutics, in support of the Newark, CA “Cell Forge One” manufacturing site. They will be responsible for many facets of the business associated with the Facilities and Engineering Department’s support of the site’s utilities, plant and equipment. The Sr. Engineer will provide system ownership, resolution of issues, and manage small to medium sized projects associated with the growth and sustained functionality of the Newark site.
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 equipment specification, troubleshooting and lifecycle management
- Lead and/or support multiple small to medium sized projects of significant complexity and risk as required
- Provides leadership and direction to engineers, 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 asset management program including maintenance needs assessment, and defining calibration and maintenance requirements
- Other duties as assigned
Position Requirements & Experience:
- This position requires a bachelor’s degree in an engineering or science discipline
- The required experience for this position is 5 – 8 years of relevant industry experience and practical experience with plant engineering or operation
- 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
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.
Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.