Senior Calibration Technician

AskBio Inc.; United States; Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

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

Responsabilités

• 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

Connaissances

Regulatory knowledge

Calibration principles

Troubleshooting

Leadership

Communication

Microsoft Office

Formation

Bachelor's degree in related field

Master's degree in related field

High School diploma with 9+ years of related work experience

Outils

Blue Mountain

ProCal

Description du poste

Opportunity for Secondment to AskBio We're pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio's mission: to advance gene therapy and change the lives of patients around the world.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

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.
• 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 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).

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

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at [phone] or sending us an email at [e-mail].