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Sun Pharmaceuticals, Inc Metrology Tech II in Billerica, Massachusetts

Metrology Tech II

Location MA, Billerica

Job Category Engineering

Employment Duration Full time

Team member responsible for ongoing metrology support for manufacturing and quality control instruments.

Responsibilities

  • Calibrate instruments such as, RO systems, WFI stills

  • Clean steam generators, Autoclaves, CIP systems, lab equipment, etc.

  • Perform scheduled, new and emergency calibrations activities with vendors on all critical process equipment and lab instrumentation ensuring compliance with SOPs and cGMPs

  • Maintain calibration records and instrument tagging

  • Write Standard Operating Procedures (SOPs)

  • Maintain calibration records and instrument tagging

  • Assist in change control documentation and deviation notifications

  • Assist in troubleshooting instrumentation issues as needed

  • Assist in performing maintenance on lab instrumentation and manufacturing equipment

  • Coordinate inventory for spare parts used on critical instruments

  • Other duties as assigned

Qualifications

  • High school diploma or equivalent is required

  • Minimum 4-6 years related experience preferred

  • Experience in temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, freeze dryer, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation

  • Knowledge of pharmaceutical-manufacturing/lab instrumentation environment

  • Strong knowledge of Blue Mountain calibration software

  • Thorough understanding of metrology principles defined in ASNI/NCSL required

  • Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, and ISO standards

  • Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation

  • Work under general supervision, utilizing some clearly described procedures and/or general technical knowledge

  • Good organizational skills

  • Ability to work independently and meet deadlines with minimal supervision

  • Excellent verbal, writing and interpersonal communication skills

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