Senior Calibration Technician
About The Position
The Senior Calibration Technician performs advanced calibration, testing, troubleshooting, and maintenance of precision instruments and equipment supporting manufacturing, research, and quality control operations. This experienced individual-contributor role provides technical guidance to other technicians, develops calibration procedures, and collaborates with Quality, Validation, Engineering, and Operations teams to maintain accurate, compliant, and reliable instrumentation. The position is onsite in Research Triangle Park, North Carolina, and reports to the Manager, Calibration and Instrumentation. The role covers calibration of critical instruments and systems, including temperature controllers, pressure transducers, pH meters, analytical balances, bioreactors, and HVAC systems. The technician develops and manages calibration schedules, maintains reference standards and calibration tools, prepares compliant records and Certificates of Calibration, investigates out-of-tolerance conditions, and supports equipment qualification and process validation. Work is primarily in cleanrooms, laboratories, or GxP-compliant facilities, with occasional calibrations in uncontrolled environments. Strict safety and gowning protocols, including PPE, apply.
Requirements
- Bachelor's degree in a related field and 5 or more years of related work experience; or a master's degree in a related field and 3 or more years of related work experience; or a high school diploma and 9 or more years of related work experience.
- In-depth understanding of FDA 21 CFR Part 11, GxP, ISO 17025, and ICH guidelines.
- Expert knowledge of calibration principles and metrology in pharmaceutical or biotechnology applications.
- Proficiency calibrating equipment such as autoclaves, incubators, chromatography systems, and environmental monitoring systems.
- Strong understanding of FDA regulations, GxP, and ISO 17025 requirements.
- Advanced troubleshooting skills for complex laboratory and manufacturing equipment.
- Proficiency with calibration management software such as Blue Mountain or ProCal, and Microsoft Office for documentation and reporting.
- Strong leadership, training, and communication skills for team guidance and cross-functional collaboration.
- Ability to lift and handle equipment up to 50 pounds, depending on the role.
- Manual dexterity for working with precision instruments in cleanroom environments.
- May be required to stand, bend, or work in controlled environments for extended periods.
Nice To Haves
- ASQ Certified Calibration Technician (CCT), Certified Quality Technician (CQT), or equivalent certification.
Responsibilities
- Perform and oversee calibration of critical instruments and systems to ensure accuracy and compliance with pharmaceutical standards.
- Train and mentor Level I and II calibration technicians and promote consistent execution of procedures and GMP adherence.
- Ensure calibration activities comply with FDA regulations, GMP, ISO 17025, and other relevant standards; maintain audit-ready documentation.
- Develop, validate, and update calibration procedures and protocols in alignment with USP, ICH guidelines, and manufacturer specifications.
- Diagnose and resolve complex process and laboratory equipment issues, and perform or oversee repairs.
- Maintain calibration records, generate Certificates of Calibration, and ensure documentation meets regulatory requirements.
- Verify calibration results against standards, investigate out-of-tolerance conditions, and implement corrective actions.
- Develop and manage calibration schedules, prioritize work, and coordinate with operations and quality teams to minimize downtime.
- Maintain and calibrate reference standards, manage calibration tools, and ensure proper storage and handling in cleanroom and controlled environments.
- Partner with quality assurance, validation, and engineering teams to support equipment qualification (IQ/OQ/PQ) and process validation.
- Identify opportunities to optimize calibration processes, implement new technologies, and improve compliance with regulatory and industry standards.
- Prepare for and support internal and external audits, including FDA and EMA audits, by providing records, procedures, and technical expertise.
- Adhere to safety and gowning protocols, including use of personal protective equipment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
