Senior Calibration Technician

Asklepios Biopharmaceutical, Inc. (Askbio); Durham (NC); Presencial; USD 85 000 - 110 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Calibration principles

Metrology

GMP

FDA 21 CFR 11

IQ/OQ/PQ

Leadership

Troubleshooting

Microsoft Office

Blue Mountain

ProCal

Formação académica

Bachelor’s degree

Master’s degree

High School diploma with 9+ years

Ferramentas

Blue Mountain

ProCal

Descrição da oferta de emprego

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 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)
• undefined

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. All employment decisions are based on valid job‑related requirements. 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].

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.