Massachusetts Jobs

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