Senior Calibration Specialist

3 weeks ago

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

Job Title: Senior Calibration Technician

Location: Research Triangle Park, NC

Duration: 3 Months

About the Role:

We are seeking a highly skilled Senior Calibration Technician to join our team at DivIHN Integration Inc. As a Senior Calibration Technician, you will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff.

Key Responsibilities:

  • Plan, schedule, and perform maintenance, calibration, and repairs on active equipment utilizing the Computerized Maintenance Management System (CMMS).
  • 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 SOPs 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, and IT.
  • 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 CMMS.
  • Adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
  • Ensure all calibration and thermal mapping activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, 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.

About DivIHN Integration Inc:

DivIHN Integration Inc is an equal opportunity employer. We do not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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