Senior Calibration Lead – Biotech GMP (Secondment)

AskBio Inc.; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

AskBio Inc. seeks a Sr. Calibration Technician to lead calibration efforts across manufacturing, research, and quality control.

You will develop procedures, mentor technicians, and ensure compliant instrumentation in GMP/GxP settings. The role is onsite in RTP, NC and reports to the Manager, Calibration and Instrumentation. You will collaborate with Quality, Validation, Engineering, and Operations to maintain accurate calibration records, support audits, and drive continuous improvement of

Qualifications

• Bachelor's degree in related field or higher, or 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 pharma/biotech
• 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 (Blue Mountain, ProCal) and Microsoft Office
• Strong leadership, training, and communication skills
• Ability to lift and handle equipment up to 50 lbs and work in cleanroom environments

Responsibilities

• Perform and oversee calibration of critical instruments and systems to ensure accuracy and compliance
• Train and mentor calibration technicians (Levels I and II)
• Ensure calibration activities comply with FDA regulations and GMP
• Develop, validate, and update calibration procedures and protocols
• Diagnose and resolve complex instrument issues and oversee repairs
• Maintain calibration records and generate Certificates of Calibration
• Support audits by providing calibration records and documentation
• Coordinate calibration schedules with operations and quality teams
• Work in cleanrooms, laboratories, or GxP facilities and follow PPE protocols

Skills

Regulatory knowledge

Calibration principles

Troubleshooting

Leadership

Communication

Microsoft Office

Education

Bachelor's degree in related field

Master's degree in related field

High School diploma with 9+ years of related work experience

Tools

Blue Mountain

ProCal

Job description

AskBio Inc. seeks a Sr. Calibration Technician to lead calibration efforts across manufacturing, research, and quality control.

You will develop procedures, mentor technicians, and ensure compliant instrumentation in GMP/GxP settings. The role is onsite in RTP, NC and reports to the Manager, Calibration and Instrumentation. You will collaborate with Quality, Validation, Engineering, and Operations to maintain accurate calibration records, support audits, and drive continuous improvement of