Job Description

Calibration Technician V

Research Triangle Park, NC 27709

6 Months

Position Overview

The Senior Calibration Technician, reporting to the Manager, Laboratory Operations, will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff at our RTP locations .

Responsibilities

· Independently plans, schedules, and performs maintenance, calibration, and repairs on active equipment utilizing the Computerized Maintenance Management System (CMMS).

· Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.

· Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.

· Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues.

· Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners.

· Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria.

· Conducts thermal mapping studies for controlled environments to validate and optimize equipment performance.

· Maintains and/or generates SOPs or other controlled documents pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment.

· Reviews system documentation, including user requirement documents and specification documents for instrumentation.

· Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.

· Contacts and obtains technical information from vendors or service providers.

· Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.

· Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.

· Ensures all calibration and thermal mapping activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).

Minimum Requirements

· High School Diploma and 9+ years of metrology experience OR Bachelor's Degree and 5+ 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.

· Experience investigating and completing CAPAs and deviations .

· 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

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