Senior Calibration Technician

AskBio Inc.; Durham (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

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

You will provide technical guidance to technicians and help ensure regulatory compliance. As an experienced contributor, you will develop calibration procedures, collaborate with Quality, Validation, Engineering, and Operations to sustain accurate instrumentation and audit-ready records in a

Qualifications

• Extensive calibration experience in GMP environments.
• Ability to develop and validate calibration procedures.
• Familiarity with regulatory standards (FDA, ISO) and audits.

Responsibilities

• Perform and oversee calibration of critical instruments to ensure accuracy and compliance.
• Train and mentor calibration technicians, ensuring GMP adherence.
• Maintain audit-ready calibration documentation and certificates.
• Develop and update calibration procedures per USP/ICH guidelines.
• Diagnose complex equipment issues and oversee repairs to maintain uptime.
• Coordinate calibration schedules with operations and quality teams.
• Prepare for and support internal and external audits with records and expertise.

Skills

Calibration expertise

GMP compliance

Regulatory documentation

Leadership/mentoring

Education

Bachelor's degree in a scientific field

Job description

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision

Pioneering science to create transformative molecular medicines.

Our mission

Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our values

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.

Position Summary

The 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 cle