Senior Calibration Technician

ALOIS Solutions; Morrisville (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

ALOIS Solutions is seeking a Calibration Technician to manage the calibration, maintenance, and repair of laboratory equipment in a GMP-regulated environment in Morrisville, NC. The role focuses on quality review of documentation and initiating deviation investigations related to metrology.

Responsibilities include performing calibration on active equipment, reviewing vendor work, ensuring FDA/GxP compliance, and maintaining calibration documentation within the CMMS.

Qualifications

• 10+ years of metrology experience with Pharma/Biotech preferred or 6+ years with a Bachelor’s Degree.
• Experience investigating CAPAs and deviations in a GxP environment.
• Strong understanding of calibration methodology, tolerances, and FDA regulations.

Responsibilities

• Manage calibration, maintenance, and repair of laboratory equipment in compliance with GxP regulations.
• Review and approve calibration and maintenance documentation performed by external vendors.
• Initiate and assist with investigations related to instrument calibration failures or issues (Deviations/CAPAs).
• Oversee onsite vendors to ensure training and compliance for calibration activities.
• Develop calibration requirements and schedules for new equipment with owners and schedulers.
• Maintain SOPs and controlled documents for the calibration program and ensure data integrity in the CMMS.

Skills

Metrology experience

CAPA investigations

GxP regulatory knowledge

Calibration methodology

Education

Bachelor’s Degree in Metrology or related field

High School Diploma

Tools

CMMS

Job description

• The Calibration Technician manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations.
• This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology.
• Individual works under the supervision and direction of more senior-level roles and uses existing procedures to solve routine or standard problems.

Calibration Execution:

• 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).

Safety and Quality Compliance:

• 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.

Asset Induction:

• 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.

Documentation:

• 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.

Required Qualifications:

• 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.