- 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, RPM, flow (liquid), pressure, load cell weigh indicators, balances, and measurement standards within a GMP facility while performing work in controlled cleanroom environments
- Knowledgeable with National Institute of Standards Technology (NIST) and/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, perform Reverse Traceability Reports, and initiate deviations as they pertain to instrumentation and equipment
- 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
- Support various groups with the resolution of deviations and CAPAs as required
- Will be required to follow, revise, and assist in the development of Standard Operating Procedures (SOP's) training modules (TRN), and technical documents for calibration
- Assist with execution of Corrective Action Preventive Action (CAPA) plans
- Must be able to prove 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 shift coverage
- Perform calibrations to process equipment and instrumentation as required by established guidelines and SOPS, Training Modules, and Technical Documents
- 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, CAPAs to instruments 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)
- Make recommendations and revise required SOPS, training modules, and technical documents for process equipment/instrumentation and support facilities
- Train calibration technicians on effective SOPs, TRN's, and TD's
- 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
- Calibration Technician II- High School Diploma and a two-year degree in engineering, life sciences, or other related technical field; or equivalent military training with 3-6 years of applicable (Metrology, instrumentation, calibration) experience
- Calibration Technician III- High School Diploma at a two-year degree in engineering, life sciences, or other related technical field; or equivalent military training with 6-9 years of applicable (Metrology, instrumentation, calibration) experience
- Prior experience in a cGMP pharmaceutical manufacturing environment
- Strong understanding of SOPS, CAPAs, and deviations
- Understand 4-20 mA Loops, Low voltage, and 120 VAC/DC
- Knowledge of NIST and/or equivalent
- Familiar with USP 41 and Handbook 44 requirements
- Familiar working within Computerized Maintenance Management System to schedule and document work performed
- Knowledge of general OSHA safety requirements and plus
- Must be able to read P&ID's and electrical schematics
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Calibration Technician II/III - Durham, United States - KBI Biopharma
Description
Position Summary
Position Responsibilities
Position Requirements
Salary : Calibration Technician II: $24.04-$33.05 per hour
Calibration Technician III: $31.61- $43.46 per hour
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
