Calibration Technician II

About the role

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.

Work is performed in a GMP facility and controlled clean room environment(s). Regular scheduled shift may consist of weekend and/or swing/grave shift coverage.

Responsibilities

• 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.
• Apply knowledge 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.
• Evaluate instrument and equipment performance, complete calculations, and perform Reverse Traceability Reports.
• Support calibration and instrumentation for NPI’s (New Product Introduction), including 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.
• Provide “On-Call” response to support plant operations during off-hours as required.
• Adhere to all safety requirements and follow all safety procedures.
• 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).
• Conduct troubleshooting using equipment manuals and drawings, identify 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 on general facility repairs including lighting, walls, floors, windows, and equipment/systems such as mechanical, electrical, pneumatic, or hydraulic circuits (motors, pumps, compressors, boilers, chillers, purified and domestic water systems).
• Perform repairs on associated equipment to calibrated loops (cords, transmitters, or probes).
• Immediately notify management or HSE when unsafe conditions or potential hazards are found; attend all required safety and health training requirements.

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.
• Prior experience in a cGMP pharmaceutical manufacturing environment preferred.
• Strong understanding of Standard Operating Procedures.
• Familiarity 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 general OSHA safety requirements a plus.
• Knowledge of hand and power tools.
• Ability to read P&ID's and electrical schematics.
• Proficiency in Microsoft Word, Excel, and Outlook.

Skills

• Reasoning Ability: Demonstrated ability to apply logical thinking and sound judgment to assess situations and solve problems using new or existing information.
• Mathematical and Engineering Skills: Proficient in problem-solving with a strong understanding of mathematical concepts and the application of engineering principles.
• Physical Demands: Ability to walk, lift, push, sit, stand, and climb as required by job tasks.
• Equipment Use: Experienced in the use of computers, telephones, plotters, copiers, and fax machines.

Working Conditions

• Work may be performed in a variety of environments, including mechanical spaces, clean room environments, and confined workspaces.
• Participation in a scheduled on-call rotation is required.