Description

You will manage laboratory equipment calibrations, maintenance, and repairs at our RTP locations.

Responsibilities

• Plan, schedule, and perform equipment maintenance and repairs using the CMMS.
• Oversee onsite vendors to ensure compliance with training and calibration requirements.
• Review and approve vendor calibration documentation following good documentation practices.
• Lead investigations into instrument calibration failures and related technical issues.
• Execute thermal mapping studies for controlled environments to validate equipment performance.
• Develop calibration requirements, schedules, and SOPs for new and existing instrumentation.

Required Skills

• 9+ years of metrology experience with a High School Diploma, or 5+ years with a Bachelor's Degree.
• Experience in the Pharma or Biotech industry.
• Deep understanding of calibration methodology, tolerances, and loop calibrations.
• Working knowledge of GMP, GLP, and GxP regulatory environments.
• Experience investigating and completing CAPAs and deviations.
• Ability to read and interpret instrument technical drawings.
• Knowledge of laboratory analytical instrumentation and small-scale manufacturing equipment.
• Familiarity with FDA, USP, and NIST regulations.
• Proficiency in using Computerized Maintenance Management Systems (CMMS).

Preferred Skills

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

Key Skills

Education

Bachelor's degree