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. Key Responsibilities 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. Required Qualifications High school diploma (GED) Minimum of five (5) years relevant work experience in calibration, metrology, instrumentation, automation, 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. Desired: 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. Core Competencies 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. The annual base pay (or hourly rate of compensation) for this position ranges from $89,874.40 - 134,811.60. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 22-Oct-2026 Closing Date 30-Oct-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

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