Calibration Lead

The Calibration Lead will be responsible for leading calibration programs, solving instrumentation and equipment issues, developing scientifically justified tolerances, operating ranges, and acceptance criteria, and ensuring that calibration activities comply with GMP, data integrity, safety, and quality requirements. The role will work closely with Manufacturing, Engineering, Quality Assurance, Validation, Automation, Facilities, and Laboratory teams to support reliable and compliant Cell Therapy operations.

• Develop and maintain risk-based calibration program for GMP equipment and instrumentation.
• Lead calibration, qualification, and validation activities for critical systems and process equipment.
• Troubleshoot calibration failures, instrument drift, repeat failures, and out-of-tolerance results.
• Perform technical impact assessments for calibration deviations and support investigations and CAPAs.
• Develop and justify calibration tolerances, operating ranges, alert limits, action limits, and acceptance criteria.
• Use equipment specifications, process requirements, historical data, measurement uncertainty, and risk assessments to establish appropriate limits.
• Review calibration trends and identify opportunities to optimise calibration frequencies and preventive maintenance.
• Prepare and review calibration procedures, protocols, reports, certificates, and technical documentation.
• Support equipment introduction, qualification, change controls, technology transfers, and decommissioning activities.
• Coordinate internal technicians and external calibration service providers.
• Ensure calibration activities are completed safely, accurately, on time, and in accordance with approved procedures.
• Maintain compliance with GMP, Good Documentation Practices, data integrity, and site quality procedures.
• Provide technical support during internal audits, regulatory inspections, and client audits.
• Collaborate with Manufacturing, Engineering, Quality Assurance, Validation, Automation, Facilities, and Laboratory teams.
• Promote continuous improvement, right-first-time execution, and reliable equipment performance.

• Degree or equivalent qualifications in Instrumentation, Electrical or Mechanical Engineering, Metrology, Automation, Biotechnology, or a related discipline.
• Minimum of five (5) years’ relevant work experience in calibration, metrology, instrumentation, validation, or maintenance within a GMP pharmaceutical, biotechnology, biologics, or Cell Therapy environment.
• Demonstrated experience troubleshooting complex instrumentation and equipment issues.
• Experience developing and reviewing tolerances, calibration ranges, acceptance criteria, alert limits, and action limits.
• Knowledge of measurement uncertainty, equipment criticality, and risk-based calibration.
• Experience with deviation investigations, CAPA, change control, qualification, and validation.
• Working knowledge of GMP, data integrity, Good Documentation Practices, and audit requirements.
• Experience with temperature, pressure, humidity, flow, level, mass, pH, conductivity, dissolved oxygen, gas concentration, speed, and environmental monitoring instruments.
• Statistical trending, calibration interval optimization, and measurement uncertainty calculations.

• Experience with calibration or maintenance management systems is desirable.
• Familiarity with EU GMP, FDA GMP, ISO/IEC 17025, and applicable metrology standards is a plus.

• Strong technical troubleshooting and root-cause analysis skills.
• Ability to make sound, science- and risk-based decisions.
• Strong understanding of GMP and data integrity requirements.
• Effective communication and stakeholder management skills.
• Ability to lead cross-functional teams and…