Calibration Lead
$89.87k - $134.81kAstraZeneca
Lead calibration programs and instrumentation management for cell therapy manufacturing operations at a pharmaceutical company. Develop risk-based calibration strategies, troubleshoot equipment issues, and ensure compliance with GMP and data integrity standards while collaborating across multiple departments.
Responsibilities
- Develop and maintain risk-based calibration programs for GMP equipment and critical systems
- Lead troubleshooting of calibration failures, instrument drift, and out-of-tolerance results
- Perform technical impact assessments for deviations and support investigations and corrective actions
- Establish scientifically justified calibration tolerances, operating ranges, and acceptance criteria using historical data and uncertainty analysis
- Coordinate internal technicians and external calibration service providers to ensure timely, accurate completion of activities
Requirements
- Bachelor's degree in Instrumentation, Electrical/Mechanical Engineering, Metrology, or related field
- Minimum 5 years calibration, metrology, or instrumentation experience in GMP pharmaceutical or biotechnology environments
- Demonstrated expertise troubleshooting complex instrumentation and equipment failures
- Experience developing and justifying calibration tolerances, acceptance criteria, and operating ranges
- Knowledge of measurement uncertainty, equipment criticality, and risk-based calibration approaches
- Proficiency with deviation investigations, CAPA, change control, and validation processes
- Working knowledge of GMP, data integrity, Good Documentation Practices, and audit compliance
Compensation: $89,874.40 - $134,811.60 base annual
Vacancy posted 16 days ago
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