GMP Calibration Lead - Cell Therapy Equipment

AstraZeneca; Los Angeles (CA); On-site; USD 90,000 - 135,000; Full time

Benefits offered by this job

Retirement plan

Health, dental, and vision coverage

Paid time off

Job summary

AstraZeneca is seeking a Calibration Lead to drive GMP calibration programs for critical equipment in Cell Therapy operations. You will collaborate with Manufacturing, Engineering, QA, Validation, Automation, Facilities, and Laboratory teams to ensure compliant, reliable performance.

The role requires five years of GMP calibration experience, strong troubleshooting and risk-based decision making, and the ability to lead cross-functional teams and external service providers in a fast-paced

Qualifications

• Degree or equivalent qualifications in instrumentation, electrical or mechanical engineering, metrology, automation, biotech or related field.
• Minimum of five years’ GMP pharma/calibration/metrology experience.
• Experience troubleshooting complex instrumentation and equipment issues.
• Knowledge of measurement uncertainty, risk-based calibration, and validation concepts.
• Experience with deviation investigations, CAPA, change control, qualification, and validation.

Responsibilities

• Develop and maintain risk-based calibration program for GMP equipment.
• Lead calibration, qualification, and validation of critical systems and process equipment.
• Troubleshoot calibration failures and instrument drift.
• Support investigations and CAPAs with technical impact assessments.
• Review calibration trends and optimise frequencies and maintenance.
• Prepare calibration procedures, reports, certificates, and technical documentation.

Skills

Technical troubleshooting

Cross-functional teamwork leadership

Communication with stakeholders

Quality/compliance focus

Education

Degree or equivalent qualifications in Instrumentation, Electrical or Mechanical Engineering, Metrology, Automation, Biotechnology, or a related discipline.

Job description

AstraZeneca is seeking a Calibration Lead to drive GMP calibration programs for critical equipment in Cell Therapy operations. You will collaborate with Manufacturing, Engineering, QA, Validation, Automation, Facilities, and Laboratory teams to ensure compliant, reliable performance.

The role requires five years of GMP calibration experience, strong troubleshooting and risk-based decision making, and the ability to lead cross-functional teams and external service providers in a fast-paced