Calibration Technician II

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 Calibration Technician II manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations. This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology. Individual works under the supervision and direction of more senior level roles and uses existing procedures to solve routine or standard problems

This is an on-site position in RTP, NC.  The Calibration Technician II reports to the Director, Facilities Operations.

Job Responsibilities

• Calibration Execution:

  • Independently perform maintenance, calibration, and repairs on active equipment, including loop calibrations

  • Review and approve equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices

  • Ensure all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP)

• Safety and Quality Compliance:

  • Adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents

  • Maintain training compliance in the Quality Management System

  • Initiate, write, and assist with investigations related to instrument calibration failures or other instrument related issues

  • Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues

• Vendor Management (Metrology):

  • Oversee and manage onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment

  • Responsible for the technical review and approval of all equipment calibration and maintenance documentation performed by external parties with a detailed eye for good documentation practices

• Asset Induction:

  • Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners and planner / scheduler

  • Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria

• Documentation:

  • Maintain and/or generate SOPs and controlled documents pertaining to the calibration program

  • Thoroughly document all activities and reviews all data to ensure completeness and accuracy within the CMMS

• Team Collaboration:

  • Interface with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT

Minimum Requirements

• High School Diploma and 6+ years of metrology experience OR Bachelor’s Degree and 2+ years of metrology experience in the Pharma/Biotech industry

• Experience investigating and completing CAPAs and deviations in a GxP environment

• Strong understanding of calibration methodology, tolerances, and FDA regulations

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 (919) 561-6210 or sending us an email at careers@askbio.com.

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.