Quick Overview
Job Description
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.
Duration: 6 Months
Location: Morrisville, NC
Job Summary
- Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations.
- Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
- Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).
- Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
- Maintain training compliance in the Quality Management System.
- Initiates, writes, and assists 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.
- Oversees and manages 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.
- 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.
- Maintains and/or generates SOPs and controlled documents pertaining to the calibration program.
- Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.
- Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.
- High School Diploma and 10+ years of metrology experience OR Bachelor’s Degree and 6+ 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.
DivIHN is an equal opportunity employer. DivIHN does not and shall 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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