Calibration Lead
About The Position
The Calibration Lead is responsible for leading calibration programs, resolving instrumentation and equipment issues, developing scientifically justified tolerances, operating ranges, and acceptance criteria, and ensuring calibration activities comply with GMP, data integrity, safety, and quality requirements. The role supports reliable and compliant Cell Therapy operations and works closely with Manufacturing, Engineering, Quality Assurance, Validation, Automation, Facilities, and Laboratory teams. The position leads risk-based calibration, qualification, and validation activities for critical systems and process equipment; investigates failures, drift, repeat issues, and out-of-tolerance results; and supports deviation impact assessments, investigations, and CAPAs. It develops calibration limits using equipment specifications, process requirements, historical data, measurement uncertainty, and risk assessments, and reviews trends to identify opportunities to optimize calibration frequencies and preventive maintenance. The Calibration Lead prepares and reviews procedures, protocols, reports, certificates, and technical documentation; supports equipment introduction, qualification, change controls, technology transfers, and decommissioning; and coordinates internal technicians and external calibration service providers. The role also supports audits and inspections while promoting safe, accurate, timely, right-first-time execution and continuous improvement.
Requirements
- Degree or equivalent qualifications in Instrumentation, Electrical or Mechanical Engineering, Metrology, Automation, Biotechnology, or a related discipline.
- Minimum of five years of 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.
- Experience with statistical trending, calibration interval optimization, and measurement uncertainty calculations.
- 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 external service providers.
- Excellent organization and prioritization skills.
- Commitment to product quality, patient safety, compliance, and continuous improvement.
Nice To Haves
- Experience with calibration or maintenance management systems.
- Familiarity with EU GMP, FDA GMP, ISO/IEC 17025, and applicable metrology standards.
Responsibilities
- Develop and maintain a 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 optimize 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.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
