Calibration Technician I - Contract

Calibration Technician I
Morrisville, NC 27560
6+ Months

Job Summary:
Position Overview
The Calibration Technician, reporting to the Manager, Calibration & Instrumentation, will support the calibration, maintenance, and repair of laboratory equipment at our RTP locations. The technician will work closely with laboratory staff, equipment owners, Quality, Facilities, Engineering, IT, and external service vendors to help ensure laboratory equipment remains properly maintained, calibrated, and compliant with applicable requirements.

Responsibilities

• Performs routine maintenance, calibration, and basic repairs on laboratory equipment under established procedures and with guidance from experienced technicians or management.
• Uses the Computerized Maintenance Management System (CMMS) to document, track, and complete equipment maintenance and calibration activities.
• Coordinates with onsite vendors and service providers to support scheduled maintenance, calibration, and repair activities.
• Assists with reviewing vendor calibration and maintenance documentation for completeness, accuracy, and compliance with good documentation practices.
• Supports investigations related to calibration failures, equipment issues, and other instrument-related problems.
• Assists with the introduction of new laboratory equipment, including helping establish calibration requirements and schedules in coordination with equipment owners and management.
• Researches equipment operating specifications and assists with identifying appropriate calibration standards and acceptance criteria.
• Assists with thermal mapping studies for controlled environments to support equipment qualification and performance monitoring.
• Assists with maintaining and updating SOPs and other controlled documents related to the operation, maintenance, and calibration of laboratory instrumentation and equipment.
• Supports the review of system documentation, including user requirements and equipment specification documents.
• Works collaboratively with laboratory staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT on laboratory equipment-related activities.
• Communicates with equipment manufacturers, vendors, and service providers to obtain technical information and support as needed.
• Accurately documents calibration, maintenance, and repair activities and enters required information into the CMMS.
• Reviews completed work and data for accuracy, completeness, and adherence to established procedures.
• Follows all applicable SOPs, company policies, safety requirements, and technical guidance documents.
• Performs calibration and thermal mapping activities in accordance with applicable industry standards and regulatory requirements, including USP, NIST, FDA, GLP, and GMP, as applicable.
• Develops technical knowledge of laboratory instrumentation, calibration practices, maintenance procedures, and applicable regulatory requirements through hands-on experience and training.
• Escalates equipment issues, calibration failures, documentation concerns, and other technical issues to the appropriate supervisor or experienced technician when additional support is required.

Minimum Requirements
High School Diploma and 1-3 years of metrology experience OR Bachelor's Degree and 0.5-2 years of metrology experience is required.
Experience working in the Pharma/Biotech industry.
Understanding of calibration methodology and tolerances.
Experience working with loop calibrations.
Understanding of FDA and GxP regulations and requirements.
Experience working in GMP, GLP environments.
Ability to read and interpret instrument technical drawings.
Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment.
Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills.
Excellent verbal and written communication skills.
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.

Preferred Requirements
Bachelor's Degree in a relevant field
Certified Calibration Technician
Experience working in CLIA, and R&D laboratory environments