5 часов назад
Calibration Technician II (Biopharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Calibration Technician II (Biopharma): Performing calibration and troubleshooting of process instrumentation and equipment in a GMP pharmaceutical manufacturing facility with an accent on metrology, instrumentation systems, and clean-room operations. Focus on evaluating instrument performance, maintaining traceability, supporting NPI and CAPA activities, and responding to plant operations during scheduled on-call rotations.
Location: USA - NC - Durham - National Way; onsite work in clean rooms, mechanical spaces, and confined workspaces
Company
operates a biopharmaceutical manufacturing facility with GMP-regulated production and cross-functional technical teams.
What you will do
- Perform calibration of temperature, humidity, timers, speed, flow, pH, conductivity, pressure, weight, balances, and other instruments according to SOPs and technical documents.
- Troubleshoot equipment using manuals and drawings, identify root causes, and assist with corrective actions for equipment failures.
- Calibrate and repair associated equipment, including cords, transmitters, probes, and calibrated loops.
- Support New Product Introduction by evaluating instruments, ranges, and tolerances against process requirements.
- Request vendor calibration quotes, coordinate contractor calibrations, and complete calculations and reverse traceability reports.
- Support deviations and CAPA plans while providing on-call response for plant operations during off-hours.
Requirements
- High school diploma plus a two-year degree in engineering, life sciences, or another related technical field, or equivalent military training.
- 3–6 years of applicable metrology, instrumentation, or calibration experience, or an equivalent combination of education and experience.
- Experience in a cGMP pharmaceutical manufacturing environment is preferred.
- Working knowledge of SOPs, computerized maintenance management systems, deviations, and CAPA.
- Basic knowledge of 4–20 mA loops, low-voltage signals, and 120 VAC/DC; ability to read P&IDs and electrical schematics.
- Ability to use hand and power tools, Microsoft Word, Excel, and Outlook, and to perform physical job tasks including walking, lifting, climbing, pushing, sitting, and standing.
Nice to have
- Knowledge of NIST or equivalent standards and secondary standard laboratories.
- Knowledge of general OSHA safety requirements.
Culture & Benefits
- Collaborative, empowered team environment with interaction across Quality Assurance, Manufacturing Operations, Engineering, and support groups.
- Work is performed in GMP-controlled clean-room and other industrial environments.
- Regular shifts may include weekends, swing shifts, or grave shifts.
- Participation in a scheduled on-call rotation is required.
- Required safety and health training and adherence to plant safety procedures.
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