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, reporting to the Manager, Calibration and Instrumentation. It is a secondment opportunity at AskBio for a duration to be determined by leadership at Bayer and AskBio. Most assignments range from one to two years, with the exact duration based on business needs and mutual agreement. The work is primarily performed in cleanrooms, laboratories, or GxP-compliant facilities, with occasional calibrations in uncontrolled environments. The technician must follow strict safety and gowning protocols, including use of personal protective equipment.
Requirements
- Bachelor’s degree in a related field and at least 5 years of related work experience; or a master’s degree in a related field and at least 3 years of related work experience; or a high school diploma and at least 9 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 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 need 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, including temperature controllers, pressure transducers, pH meters, analytical balances, bioreactors, and HVAC systems.
- Train and mentor Level I and II calibration technicians, promoting consistent procedures and adherence to Good Manufacturing Practices (GMP).
- Ensure calibration activities comply with FDA regulations, including 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 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 records, procedures, and technical expertise.
- Work primarily in cleanrooms, laboratories, or GxP-compliant facilities and occasionally perform calibrations in uncontrolled environments.
- Follow safety and gowning protocols, including use of personal protective equipment (PPE).
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What This Job Offers
Job Type
Full-time
Career Level
Senior
