Calibration Technician

ALOIS Solutions; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

ALOIS Solutions is seeking an experienced Calibration Technician V for our pharma/biotech laboratory environment. The role emphasizes metrology, loop calibrations, deviation investigations, and CAPA, with a focus on GMP/GxP compliance and FDA documentation.

You will review vendor records, manage calibration documentation, and oversee onsite calibration vendors while maintaining SOPs in CMMS. A senior-level candidate with extensive metrology background is required.

Qualifications

• 10+ years metrology experience with pharmaceutical/biotech labs.
• Hands-on loop calibration expertise and calibration methodology.
• Experience with CAPA, deviation investigations, and GxP compliance.
• Strong knowledge of FDA regulations and quality systems.
• Ability to review and approve calibration records and maintenance docs.
• Experience managing calibration vendors and CMMS records.

Responsibilities

• Independently perform calibration, maintenance, repairs, and loop calibrations.
• Review and approve vendor calibration records and maintenance docs.
• Investigate calibration failures, deviations, and CAPAs.
• Ensure GMP/GLP/GxP, FDA, USP and NIST compliance.
• Oversee onsite calibration vendors and ensure training compliance.
• Support new equipment induction, schedules, acceptance criteria.
• Maintain SOPs and equipment records in CMMS.

Skills

Loop calibrations

Deviation investigations

CAPA

GxP compliance

FDA regulations

Calibration documentation

Education

High School Diploma

Bachelor’s Degree

Tools

CMMS

Job description

Work Environment: Laboratory / Pharma-Biotech

Ready to take your calibration and metrology expertise to the next level?

We’re looking for an experienced Calibration Technician V with a strong background in pharmaceutical/biotech environments, laboratory instrumentation, and GxP compliance. If you have hands-on experience with loop calibrations, deviation investigations, and CAPAs, this could be your next opportunity!

• Independently perform equipment calibration, maintenance, repairs, and loop calibrations.


• Review and approve vendor calibration records and maintenance documentation, ensuring accuracy and compliance with Good Documentation Practices.


• Initiate, document, and support investigations related to calibration failures, deviations, and CAPAs.


• Ensure compliance with GMP, GLP, GxP, FDA, USP, and NIST requirements, as applicable.


• Oversee onsite calibration vendors and ensure adherence to training, quality, and compliance standards.


• Support new equipment induction, calibration schedules, acceptance criteria, and maintenance requirements.


• Maintain and update SOPs, controlled documents, and equipment records within CMMS.

• High School Diploma with 10+ years of metrology experience, OR a Bachelor’s Degree with 6+ years of metrology experience.


• Experience in the Pharmaceutical / Biotechnology industry.


• Hands-on expertise in loop calibration, calibration methodology, and tolerances.


• Proven experience with CAPA, deviation investigations, and GxP compliance.


• Strong understanding of FDA regulations, calibration documentation, and quality systems.