Calibration Technician

Job Title: Calibration Technician - Metrology

Location: Morrisville, NC 27560

Duration: 07 months (possibility of extension)

Job Summary:

We are seeking an experienced Calibration Technician to support laboratory equipment calibration, maintenance, troubleshooting, and repairs in a regulated pharmaceutical or biotechnology environment. The ideal candidate will ensure compliance with GxP requirements, FDA regulations, and Good Documentation Practices (GDP). This role will also support deviation investigations, CAPAs, equipment onboarding, and calibration program documentation.

Key Responsibilities:

Calibration and Maintenance

• Perform calibration, preventive maintenance, troubleshooting, and repairs on laboratory equipment, including instrument loop calibrations.
• Review and approve calibration and maintenance documentation completed by external vendors.
• Ensure calibration activities meet established tolerances, acceptance criteria, and applicable regulatory requirements.

Quality and Compliance

• Initiate, document, and support investigations related to calibration failures and instrument issues.
• Prepare and support deviations and Corrective and Preventive Actions (CAPAs) in a GxP environment.
• Follow established SOPs, company policies, and applicable FDA, GMP, GLP, USP, and NIST requirements.
• Maintain required training and compliance records within the Quality Management System.

Vendor and Equipment Management

• Coordinate onsite vendors performing laboratory equipment calibration, maintenance, and repairs.
• Ensure vendors meet applicable training, safety, and quality requirements.
• Support the onboarding of new equipment by establishing calibration requirements, schedules, and acceptance criteria.
• Research equipment specifications and identify appropriate calibration standards.

Documentation and Collaboration

• Maintain and update SOPs and controlled documents related to the calibration program.
• Record and review calibration activities in the Computerized Maintenance Management System (CMMS), ensuring data accuracy and completeness.
• Collaborate with Laboratory Operations, Quality Assurance, Engineering, Facilities, IT, and Computer Systems Validation teams.

Required Qualifications:

• High School Diploma with 10+ years of metrology experience , or a Bachelor's degree with 6+ years of metrology experience in the pharmaceutical or biotechnology industry.
• Hands-on experience with laboratory equipment calibration, maintenance, troubleshooting, and repairs.
• Experience initiating and completing deviations and CAPAs in a regulated GxP environment.
• Strong understanding of calibration methodologies, tolerances, acceptance criteria, and FDA regulations.
• Knowledge of GMP, GLP, USP, NIST, and Good Documentation Practices.
• Experience reviewing vendor calibration records and maintaining controlled documentation.
• Strong attention to detail, documentation, problem-solving, and cross-functional communication skills.

Preferred Skills:

• Experience with CMMS and Quality Management Systems (QMS).
• Experience with laboratory equipment onboarding and calibration schedule development.
• Ability to work independently while following established procedures and quality standards.

Work Environment:

This position supports laboratory operations in a regulated pharmaceutical or biotechnology environment and requires collaboration with internal teams and external service providers.

Interested candidates: Apply today to explore this opportunity and contribute your metrology expertise to a quality-driven laboratory environment.