Title:  Metrology Technician II

Job Summary

Provides ongoing support for manufacturing and quality control instruments.  Responsible for installing, maintaining, testing, repairing, and calibrating a diverse range of electrical and mechanical equipment while adhering to good manufacturing practices.

Area Of Responsibility

• Calibrate instruments such as, RO systems, WFI stills, clean steam generators, Autoclaves, CIP systems, lab equipment, and manufacturing equipment.
• 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
• Basic knowledge on cleanroom classifications, and HEPA and cleanroom certification
• Write Standard Operating Procedures (SOPs)
• Must be proficient in troubleshooting instrument control loops like temperatures, pressure, flow controllers etc…
• Follow all environmental, health, and safety requirements and protocols
• Proficient at reading and understanding schematics, logic ladder diagrams, and P&IDs
• Assist in change control documentation and deviation notifications
• Write initial deviations using the QMS system
• Perform new instrument and equipment introduction using the qualified CMMS
• 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
• Support operations during 1st shift, and be available after hours as needed to support the business

• Other duties as assigned

Work Conditions:

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, sit, walk, stoop, climb, use hands and fingers to  handle or feel, reach with hands and arms
• Close and distance vision, talk, hear
• Wears personal protection equipment - safety glasses, gloves, gowning
• Use of autoclave
• Operates computer/office machines
• Exposure to noise
• Lift up to 25 lbs.

Travel Estimate

Up to     0   %

Education and Job Qualification

• High school diploma or equivalent is required
• Associate degree in STEM preferred
• Journeyman Certified Electronic Technician certification from an accredited agency is preferred
• Certified Control Systems Technician Level 1 from an accredited agency is preferred

• 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

Experience

• Minimum 4+ 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
• Experience soldering, use of DMM, and oscilloscopes
• Knowledge of pharmaceutical-manufacturing/lab instrumentation environment
• Experience utilizing quality manage systems like Trackwise, EDMS, MasterControl, or equivalent
• Strong knowledge of Blue Mountain calibration software or equivalent
• Thorough understanding of metrology principles defined in ASNI/NCSL required
• Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, EU and ISO standards
• Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).