GMP Maintenance Technician – Cleanroom & Process Equipment

AstraZeneca GmbH

Santa Monica (CA)

On-site

USD 72,000 - 108,000

Full time

5 days ago
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Benefits offered by this job

Health, dental, vision coverage
Paid time off
Retirement programs

Job summary

AstraZeneca GmbH is seeking an experienced Maintenance Technician to ensure GMP-compliant maintenance of cell therapy process equipment. You will support cleanroom operations, perform preventive and corrective maintenance, and collaborate with QA and Engineering on root cause analyses.

The role requires strong GMP knowledge, CMMS proficiency, and hands-on calibration/qualification experience in regulated facilities.

Qualifications

  • High school diploma or technical training in mechanical/electrical fields; associate/technical degree a plus.
  • 6–10+ years GMP biopharma/cell therapy maintenance experience in cleanrooms and regulated utilities.
  • Strong knowledge of cGMP, GDP, change control, deviation/CAPA, and validation/qualification principles.

Responsibilities

  • Perform and document preventive, predictive, and corrective maintenance on cell therapy process equipment.
  • Maintain cleanrooms in ISO-classified environments; protect validated state during maintenance and return-to-service.
  • Troubleshoot equipment and utilities; drive root cause analysis and implement CAPAs with QA/Engineering.
  • Complete GMP documentation contemporaneously (work orders, logs, deviations, change controls, calibrations).
  • Coordinate calibration of critical instruments and ensure traceability to standards.

Skills

GMP Maintenance
Cleanroom Support
Troubleshooting & RCA
Documentation & Compliance
Calibration & Metrology
Validation Support
Asset & CMMS Management
Safety & EHS
Continuous Improvement

Education

High School Diploma
Associate/Technical Diploma

Tools

CMMS
EMS
PLC/HMI

Job description

AstraZeneca GmbH is seeking an experienced Maintenance Technician to ensure GMP-compliant maintenance of cell therapy process equipment. You will support cleanroom operations, perform preventive and corrective maintenance, and collaborate with QA and Engineering on root cause analyses.

The role requires strong GMP knowledge, CMMS proficiency, and hands-on calibration/qualification experience in regulated facilities.

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