Job Description
Job Title: Calibration Technician V
Location: 507 Airport Blvd, Morrisville, North Carolina, USA – 27560
Duration: 6 Months Contract (W2 Only)
Position Overview
The Senior Calibration Technician, reporting to the Manager, Laboratory Operations, is responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff at RTP locations.
Key Responsibilities
- Independently plan, schedule, and perform maintenance, calibration, and repairs on active equipment using the Computerized Maintenance Management System (CMMS).
- Oversee and manage onsite vendors to ensure training and compliance requirements are met for maintenance, calibration, and repair activities.
- Review and approve equipment calibration and maintenance documentation completed by external vendors, ensuring adherence to good documentation practices.
- Initiate, write, and assist with investigations related to instrument calibration failures or instrument-related issues.
- Support induction of new equipment, including development of 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 and controlled documents related to operation, maintenance, and calibration of laboratory instrumentation and equipment.
- Review system documentation including user requirement specifications and instrument specification documents.
- Interface with multidisciplinary teams including laboratory staff, Quality Assurance, Computer Systems Validation, Facilities, Engineering, and IT.
- Contact vendors and service providers to obtain technical information.
- Document all activities thoroughly and review data for completeness and accuracy within CMMS.
- Follow all applicable Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
- Ensure calibration and thermal mapping activities comply with industry regulations such as USP, NIST, FDA, GLP, and GMP.
Minimum Requirements
- High School Diploma with 9+ years of metrology experience OR Bachelor’s Degree with 5+ years of metrology experience.
- Experience working in Pharma/Biotech industry.
- Understanding of calibration methodologies and tolerances.
- Experience with loop calibrations.
- Understanding of FDA and GxP regulations.
- Experience working in GMP and GLP environments.
- Experience investigating and completing CAPAs and deviations.
- Ability to read and interpret instrument technical drawings.
- Working knowledge of laboratory analytical instrumentation and small-scale manufacturing equipment.
- Ability to work independently in a fast-paced, collaborative environment.
- Ability to work effectively within multidisciplinary teams.
Preferred Requirements
- Bachelor’s Degree in a relevant field.
- Certified Calibration Technician certification.
- Experience working in CLIA and R&D laboratory environments.
