Senior Engineer, Facilities

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 Allogenes manufacturing facility in Newark CA and Allogenes 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 SOPs 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 CAPAs
• 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:

• Bachelors 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 $135000 to $160000 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.

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