Calibration Technician II

KBI Biopharma • Durham, NC

8d • Onsite

About The Position

The calibration technician works within a team environment that actively supports, participates, and embraces an empowered team culture including significant interaction with Quality Assurance, Manufacturing Operations, Engineering, and other support groups. Perform Calibration to instrumentation that includes but is not limited to Temperature, Relative Humidity (RH), Timers, Speed (RPM), Flow, pH, Conductivity, Pressure, Load Cell Weight Indicators, Balances, and measurement Standards within a GMP facility while performing work in controlled clean room environment(s). Knowledgeable of National Institute of Standards Technology (NIST) or equivalent and Secondary Standard Laboratories. Request calibration quotes from vendors and assist with on-site calibrations by calibration contractors. Must be able to evaluate instrument and equipment performance, complete calculations, and perform Reverse Traceability Reports. Support calibration and instrumentation for NPI’s (New Product Introduction), which includes but is not limited to evaluation of current and future instruments and their range(s) / tolerance(s) to meet process requirements. Assist with execution of Corrective Preventive Action (CAPA) plans. Must be able to provide “On-Call” response to support plant operations during off-hours as required. Adhere to all safety requirements and follow all safety procedures. Regular scheduled shift may consist of weekend and/or swing/grave shift coverage.

Requirements

• High School diploma and a two-year degree in Engineering, Life Sciences, other related technical field or equivalent military training with 3 - 6 years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience.
• Strong understanding of Standard Operating Procedures.
• Familiar working within Computerized Maintenance Management Systems to schedule and document work performed.
• Basic knowledge of 4-20 mA loops, low voltage signals, 120 VAC/DC.
• Knowledge of Deviations and CAPA’s.
• Knowledge of hand and power tools.
• Must be able to read P&ID's and electrical schematics.
• Must be able to use Word, Excel and Outlook.
• Demonstrated ability to apply logical thinking and sound judgment to assess situations and solve problems using new or existing information.
• Proficient in problem-solving with a strong understanding of mathematical concepts and the application of engineering principles.
• Must be able to walk, lift, push, sit, stand, and climb as required by job tasks.
• Experienced in the use of computers, telephones, plotters, copiers, and fax machines.

Nice To Haves

• Prior experience in a cGMP pharmaceutical manufacturing environment preferred.
• Knowledge of general OSHA safety requirements a plus.

Responsibilities

• Perform calibration to process equipment and instrumentation as required by established guidelines and Standard Operating Procedures (SOP’s), Training Modules (TRN), and Technical Documents (TD).
• Ability to conduct troubleshooting by use of equipment manuals and drawings, identifying root cause, and assist in determining appropriate corrective actions for equipment failures.
• Generate and assist with resolving Deviations, CAPA’s to instrument and equipment.
• Assist and troubleshoot with maintenance personnel with general facility repairs not to exclude lighting, walls, floors, windows as well as troubleshoot equipment and systems, including mechanical, electrical, pneumatic, or hydraulic circuits (motors, pumps, compressors, boilers, chillers, and purified and domestic water systems).
• Perform repairs on associated equipment to calibrated loops (cords, transmitters, or probes).
• Provide “On-Call” response to support plant operations during off-hours as required.
• Adhere to all safety requirements and follow safe procedures, immediately notifying management or HSE when unsafe conditions or potential hazards are found; attend all required safety and health training requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree