Calibration Technician V

• 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).

• 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.

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

akarsh.yathiraj@leadstackinc.com