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. This is an onsite position based in RTP, NC. The position reports to the Manager, Calibration and Instrumentation. The role primarily works in cleanrooms, laboratories, or GxP-compliant facilities and may occasionally involve calibrations in uncontrolled environments. The technician must follow strict safety and gowning protocols, including use of personal protective equipment (PPE).
Requirements
- Bachelor’s degree in a related field with 5 or more years of related work experience; or a master’s degree in a related field with 3 or more years of related work experience; or a high school diploma with 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 biotech 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 management and cross-functional collaboration.
- Ability to lift and handle equipment weighing up to 50 pounds, depending on the role.
- Manual dexterity to work with precision instruments in cleanroom environments.
- Ability to stand, bend, or work in controlled environments for extended periods may be required.
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, including temperature controllers, pressure transducers, pH meters, analytical balances, bioreactors, and HVAC systems.
- Train and mentor Level I and II calibration technicians, ensuring consistent execution of procedures and adherence to GMP.
- Ensure calibration activities comply with FDA regulations, 21 CFR Part 11, GMP, ISO 17025, and other relevant standards, and 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 issues with process and laboratory equipment, and perform or oversee repairs.
- Maintain detailed calibration records, generate Certificates of Calibration, and ensure documentation meets regulatory requirements for audits and inspections.
- Verify calibration results against standards, investigate out-of-tolerance conditions, and implement corrective actions.
- Develop and manage calibration schedules, prioritize tasks, and coordinate with operations and quality teams to minimize downtime.
- Maintain and calibrate reference standards, manage calibration tools, and ensure proper equipment storage and handling in cleanroom and controlled environments.
- Collaborate with quality assurance, validation, and engineering teams on equipment qualification (IQ/OQ/PQ) and process validation activities.
- 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 calibration records, procedures, and technical expertise.
- Work primarily in cleanrooms, laboratories, or GxP-compliant facilities; occasionally perform calibrations in uncontrolled environments.
- Follow safety and gowning protocols, including use of PPE.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
