Facilities Metrology Technician II

A brief overview

The Facilities Metrology Technician II, under close supervision, performs routine calibration duties such as tests, calibrations, repairing electrical, mechanical, electro-mechanical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established standards. This individual will also be responsible for all related projects and services related to facility equipment and their timely completion while adhering to standard practices. In addition, he/she will be responsible for routine visual and physical inspections.

What you will do

• Disassemble instruments and equipment and inspect components for defects Reassemble and calibrate instruments and equipment
• Measure parts for conformity with specifications
• Aligns, repairs, replaces, and balances component parts and circuitry
• Devise formulas to solve problems in measurements and calibrations
• Perform all in-house calibrations and maintain appropriate documentation
• Ensure all calibration standards are properly calibrated and certified
• Execute engineering and calibration portions of equipment qualifications
• Monitor HVAC parameters and changes temperature/humidity charts weekly
• Schedules, calibrates and verifies calibration of instrumentation under the Metrology program
• Assist in specifying instruments and standards and in drafting new and revised SOPs
• Participate in training programs which result in the development of a successful working understanding of the material presented, and to become proficient in assigned duties and tasks
• Comply with all Company policies and procedures, including safety rules and regulations
• Monitor cGMP stability chambers daily and enter the temperature and humidity data into a Laboratory Management System.
• Monitor cGMP stability chamber chart recordings and charge charts on a weekly basis.
• Monitor cGMP refrigerators and freezers daily and enter the temperature data into a Laboratory Management System.
• Daily check of Milli-Q water systems and enter data into a Laboratory Management System.
• Daily check/calibration of analytical balances and enter data into a Laboratory Management System.
• Check dissolution baths and all associated components for proper serialization and cleanliness.
• Receive gas tank orders and coordinate with the delivering vendor.
• Calibration of analytical equipment including ovens, dissolution baths, dissolution autosamplers, IR, UV, Muffle furnace, stirrers, shakers, centrifuge, water baths, disintegrator, moisture balance, etc.
• Perform IQ, IQ, PQ for analytical equipment’s.
• Write, revise, and update the Standard Operating Procedures (SOP’s) for analytical equipment.
• Coordinate internal and external calibration activity, shipping and receiving etc.
• Maintain instrument related documentation.
• Work with 3rd party vendors to ensure company standards and documentation procedures are met.

Qualifications

• Associate's degree or trade school certification with 5 years relevant experience or
• High School Diploma or equivalent with 7 years relevant experience
• Ability to maintain a high level of documentation and audit trail for calibrated systems such as PLCS, Building Management Systems and other Controls monitoring systems
• Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), ISO and other regulatory requirements
• Experience with the principles and practices of metrology
• Principles of mathematical and statistical computations
• Experience with proper techniques of instrumentation repair Knowledge of techniques of calibration (temperature, pressure, dimensional, mass, humidity)
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Detail oriented with the ability to troubleshoot and resolve problems Communicate effectively and ability to function well in a team environment
• Ability to work independently and manage one’s time
• Flexibility of working hours based on business needs, may include some nights and occasional weekends Must be able to work a rotating on-call schedule, including weekends
• Certifications in Metrology (preferred)