Calibration Technician/Senior Calibration Technician, Facilities
Facilities | Newark, CA | Full Time
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated Calibration Technician/Senior Calibration Technician, Facilities to join our team here at our biotechnology facility that includes general laboratories and manufacturing for bio-processing. In addition to facilities oversight activities, the Calibration Technician will assist in the operation and maintenance of the company’s facility for production of cell-based therapeutics. We strive to ensure manufacturing and all labs and lab personnel are supported to meet business needs, as well as all other facility support requests that lay the foundation to a world class support organization.
Responsibilities include, but are not limited to:
- Apply knowledge of measurement science, mathematics, physics, and electronics to calibrate, troubleshoot, and maintain a variety of equipment to ensure measurement accuracy.
- Support and provide technical assistance in GMP and non-GMP facilities. Escort/support vendors as needed.
- Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.
- Assist with identification, purchase, and organization of spare parts.
- Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
- Support and take direction from Facilities, Lab and Engineering team members required to sustain functionality of their areas.
- Assist in facility services including cleaning of process equipment and instrumentation, performing basic maintenance in process machinery and weekly rounds.
- Work independently and make sound judgments regarding work methods, tools and standards used.
- Ensure facility and all labs and lab/manufacturing personnel are supported to meet business needs, including lab gasses, preventive maintenance, equipment service contracts, calibration and safety equipment.
- Follow instructions to ensure compliance with all applicable regulatory agencies including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
- Work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
- Work in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery
- Able to work after hours and on call as needed; weekend shift support and shutdowns
- Other duties as assigned
Position Requirements & Experience
- High School diploma, relevant trade certification, or college training in engineering or manufacturing/analytical process instrumentation or equivalent experience required with at least 2+ years of GMP calibration and maintenance experience in a biotech or pharmaceutical company.
- Experience in calibration of temperature, pressure, humidity, level, flow, and analytical instrumentation (scales, pH, conductivity, etc.)
- Computer skill level appropriate to navigate and use CMMS/CCMS, and standard word processing and spreadsheet programs.
- Must be detail oriented and able to carry out and follow instructions.
- Previous experience with CMMS and Environmental Monitoring Systems is required. Familiarity with Blue Mountain is a plus.
- Demonstrated understanding of systems needed to manage a GMP facility such as: HVAC, electrical, process systems, plumbing/piping, general maintenance.
- Understanding of building P&IDs, as-built, schematics and flow diagram and electrical, is desired however, not required.
- Must be able to lift, carry, push and/or pull 50 lb. of equipment or supplies.
- Must be able to squat, bend, kneel, climb, and or reach for 75% of an 8-hour shift
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the 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.
- Experience in operating a BMS system, preferred.
- Candidates must be authorized to work in the U.S.
- Valid CA driver’s license and ability to be covered by the company’s vehicle insurance policy.
As an equal opportunity employer, Allogene Inc. 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.