Lead Calibration Technician – GMP & ISO 17025 Expert

Asklepios Biopharmaceutical, Inc. (Askbio); Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

AskBio Inc. in RTP, NC seeks a Sr. Calibration Technician to perform advanced calibration, testing, troubleshooting, and maintenance of precision instruments supporting manufacturing, research, and quality control.

This onsite role reports to the Manager, Calibration and Instrumentation. The position collaborates with Quality, Validation, Engineering, and Operations to maintain instrument accuracy and regulatory compliance in cleanrooms and labs.

Qualifications

• Bachelor’s degree with 5+ years related experience.
• Master’s degree with 3+ years related experience.
• High School diploma with 9+ years related 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/biotech applications.
• Proficiency with calibration of equipment such as autoclaves, incubators, chromatography systems, and environmental monitoring systems.

Responsibilities

• Advanced Calibration: Perform and oversee calibration of critical instruments and systems to ensure accuracy and compliance with pharmaceutical standards.
• Team Leadership: Train and mentor calibration technicians, ensuring adherence to GMP.
• Regulatory Compliance: Ensure all calibration activities comply with FDA regulations, GMP, ISO 17025, and other standards, maintaining audit-ready documentation.
• Procedure Development: Develop, validate, and update calibration procedures and protocols to align with USP, ICH, and manufacturer specs.
• Troubleshooting and Maintenance: Diagnose and resolve complex lab/manufacturing equipment issues and perform repairs.
• Documentation and Reporting: Maintain detailed calibration records and generate Certificates of Calibration for audits.
• Quality Assurance: Verify results, investigate out-of-tolerance conditions, and implement corrective actions.
• Calibration Program Management: Develop calibration schedules and coordinate with operations and quality to minimize downtime.
• Equipment Oversight: Maintain reference standards and ensure proper storage/handling in cleanrooms.
• Collaboration: Partner with QA, validation, and engineering for IQ/OQ/PQ and process validation.
• Continuous Improvement: Identify opportunities to optimize calibration processes and ensure regulatory compliance.
• Audit Support: Prepare for internal and external audits by providing records and procedures.

Skills

Calibration principles

Metrology

GMP

FDA 21 CFR 11

IQ/OQ/PQ

Leadership

Troubleshooting

Microsoft Office

Blue Mountain

ProCal

Education

Bachelor’s degree

Master’s degree

High School diploma with 9+ years

Tools

Blue Mountain

ProCal

Job description

AskBio Inc. in RTP, NC seeks a Sr. Calibration Technician to perform advanced calibration, testing, troubleshooting, and maintenance of precision instruments supporting manufacturing, research, and quality control.

This onsite role reports to the Manager, Calibration and Instrumentation. The position collaborates with Quality, Validation, Engineering, and Operations to maintain instrument accuracy and regulatory compliance in cleanrooms and labs.