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Senior Calibration Specialist

2 months ago

Durham, North Carolina, United States DivIHN Integration Inc Full time
Job Summary

We are seeking a highly skilled Senior Calibration Specialist to join our team at DivIHN Integration Inc. As a key member of our laboratory operations team, you will be responsible for managing laboratory equipment calibrations, maintenance, and repairs.

Key Responsibilities
  • Independently plan, schedule, and perform maintenance, calibration, and repairs on active equipment utilizing a computerized maintenance management system.
  • Oversee and manage onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.
  • Review and approve equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
  • Initiate, write, and assist with investigations related to instrument calibration failures or other instrument-related issues.
  • Induce new equipment, including developing calibration requirements and schedules in coordination with equipment owners.
  • Research operating specifications of new equipment, obtain suitable standards, and establish calibration acceptance criteria.
  • Conduct thermal mapping studies for controlled environments to validate and optimize equipment performance.
  • Maintain and/or generate standard operating procedures or other controlled documents pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment.
  • Review system documentation, including user requirement documents and specification documents for instrumentation.
  • Interface with multi-disciplinary teams regarding laboratory equipment, including lab staff, quality assurance, computer systems validation, facilities, and engineering.
  • Contact and obtain technical information from vendors or service providers.
  • Thoroughly document all activities and review all data to ensure completeness and accuracy within the computerized maintenance management system.
  • Adhere to all applicable written standard operating procedures, company policies, and technical guidance documents, both internal and external.
  • Ensure all calibration and thermal mapping activities comply with relevant industry regulations, such as USP, NIST, FDA, GLP, and GMP.
Requirements
  • High school diploma and 9+ years of metrology experience or bachelor's degree and 5+ years of metrology experience is required.
  • Experience working in the pharma/biotech industry.
  • Understanding of calibration methodology and tolerances.
  • Experience working with loop calibrations.
  • Understanding of FDA and GxP regulations and requirements.
  • Experience working in GMP, GLP environments.
  • Experience investigating and completing CAPAs and deviations.
  • Ability to read and interpret instrument technical drawings.
  • Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment.
  • Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills.
  • Excellent verbal and written communication skills.
  • Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
Preferred Requirements
  • Bachelor's degree in a relevant field.
  • Certified calibration technician.
  • Experience working in CLIA and R&D laboratory environments.