Lead Calibration Technician – Pharma/GxP

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

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.