Calibration Technician III

5 days ago


Boulder, Colorado, United States KBI BioPharma Full time
Job Summary:

As a Calibration Technician III at KBI Biopharma, you will play a critical role in ensuring the accuracy and reliability of our manufacturing processes. You will be responsible for performing calibration and maintenance functions on process equipment and instrumentation, as well as troubleshooting and resolving issues related to equipment failures. Your expertise in metrology and instrumentation will be essential in maintaining compliance with cGMP regulations and ensuring the quality of our products.

Key Responsibilities:

  • Perform calibration and maintenance functions on process equipment and instrumentation, including temperature, relative humidity, timers, RPM, flow, pressure, load cell weight indicators, balances, and measurement standards.
  • Troubleshoot and resolve issues related to equipment failures, including identifying root causes and implementing corrective actions.
  • Collaborate with quality assurance, manufacturing operations, and engineering teams to ensure compliance with cGMP regulations and maintain the quality of our products.
  • Develop and maintain Standard Operating Procedures (SOPs), Training Modules (TRNs), and Technical Documents (TDs) for calibration and maintenance functions.
  • Provide on-call support for plant operations during off-hours, including nights and weekends.
  • Adhere to all safety requirements and follow safe procedures to ensure a safe working environment.

Requirements:

  • High school diploma and a two-year degree in engineering, life sciences, or a related technical field, or equivalent military training and 5-9 years of applicable experience.
  • Prior experience in a cGMP pharmaceutical manufacturing environment.
  • Strong understanding of Standard Operating Procedures, Corrective Preventive Actions, and Deviations.
  • Knowledge of National Institute of Standards Technology (NIST) and/or equivalent.
  • Familiarity with USP 41 requirements.
  • Familiarity with Computerized Maintenance Management System (CMMS) and Blue Mountain Ram Regulatory Asset Manager operating system.
  • Ability to read P&ID's and electrical schematics.
  • Excellent communication and teamwork skills.

Working Conditions:

Clean room environments.

Hours of Work: 10-hour shift, 7:00 am - 5:30 pm, Sunday - Wednesday.

Salary Range: $43.46 per hour.

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