Metrologist
Core
Perform and document calibrations for a wide range of instruments (temperature, RPM, weight, pH, DO, flow, pressure) in a highly regulated GMP biopharmaceutical setting.
Role type
Metrologist
Builds
Calibration and preventive maintenance programs for manufacturing and laboratory equipment
Domain
Biopharmaceutical manufacturing (Gene Therapies, AAV, viral vectors)
Deliverable
physical/clinical work
Required skills
Metrology, GMP environment experience, equipment calibration, SOP creation, vendor coordination, GMP documentation, CMMS management, asset management
Preferred skills
Calibration or Metrology certification
Responsibilities
Create and review calibration SOPs, coordinate with subcontractors for calibrations and repairs, maintain calibration and preventive maintenance program, generate documentation (change control, deviations, CAPAs), maintain equipment logbooks and records in CMMS, procure equipment parts and instrumentation, troubleshoot equipment and instrumentation issues
Seniority
Mid-level, hands-on IC