Position SummaryThe Sr. 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 will report to the Manager, Calibration and Instrumentation.
Job Responsibilities- Advanced Calibration: Perform and oversee calibration of critical instruments and systems (e.g., temperature controllers, pressure transducers, pH meters, analytical balances, bioreactors, and HVAC systems) to ensure accuracy and compliance with pharmaceutical standards
- Team Leadership: Train, and mentor calibration technicians (Levels I and II), ensuring consistent execution of calibration procedures and adherence to Good Manufacturing Practices (GMP)
- Regulatory Compliance: Ensure all calibration activities comply with FDA regulations (21 CFR Part 11), GMP, ISO 17025, and other relevant standards, maintaining audit-ready documentation
- Procedure Development: Develop, validate, and update calibration procedures and protocols, ensuring alignment with USP, ICH guidelines, and manufacturer specifications
- Troubleshooting and Maintenance: Diagnose and resolve complex issues with process and laboratory equipment, performing or overseeing repairs to maintain compliance and operational efficiency
- Documentation and Reporting: Maintain detailed calibration records, generate Certificates of Calibration, and ensure documentation meets regulatory requirements for audits and inspections
- Quality Assurance: Verify calibration results against standards, investigate out-of-tolerance conditions, and implement corrective actions to ensure product quality and compliance
- Calibration Program Management: Develop and manage calibration schedules, prioritize tasks, and coordinate with operations and quality teams to minimize downtime in manufacturing and laboratory environments
- Equipment Oversight: Maintain and calibrate reference standards, manage calibration tools, and ensure proper storage and handling of equipment in cleanroom and controlled environments
- Collaboration: Partner with quality assurance, validation, and engineering teams to support equipment qualification (IQ/OQ/PQ) and process validation activities
- Continuous Improvement: Identify opportunities to optimize calibration processes, implement new technologies, and enhance compliance with regulatory and industry standards
- Audit Support: Prepare for and support internal and external audits (e.g., FDA, EMA) by providing calibration records, procedures, and technical expertise
- Primarily work in cleanrooms, laboratories, or GxP compliant facilities
- May occasionally perform calibrations in uncontrolled environments
- Adhere to strict safety and gowning protocols, including the use of personal protective equipment (PPE)
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Minimum Requirements- Bachelor's degree in related field with 5+ years of related work experience; OR Master's degree in related field with 3+ years of related work experience; OR High School diploma with 9+ years of related work experience
- Regulatory Knowledge: In-depth understanding of FDA 21 CFR Part 11, GxP, ISO 17025, and ICH guidelines
- Expert knowledge of calibration principles and metrology in pharmaceutical/biotech applications
- Proficiency with calibration of 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 in calibration management software (e.g., Blue Mountain, 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 (up to 50 lbs, depending on the role)
- Manual dexterity for working with precision instruments in cleanroom environments
- May require standing, bending, or working in controlled environments for extended periods
Preferred Education, Experience and Skills- ASQ Certified Calibration Technician (CCT), Certified Quality Technician (CQT), or equivalent certifications
