Metrology Technician

Eisai US
Baltimore, MD
May 21, 2019
May 24, 2019
Full Time
The Metrology Technician is responsible for performing all scheduled and unscheduled instrument calibrations supporting facility, laboratory, and production operations to ensure GMP compliance, equipment/process reliability, and safety/environmental standards. These activities will be performed per Standard Operating Procedures (SOPs) and per industry standards. This position is responsible for ensuring that calibration data is recorded utilizing good documentation practices and is maintained in the calibration database and instrument files. The Metrology Technician is also responsible for the analysis and diagnosis of instrument failures and the recommendation for instrumentation improvements for existing equipment installations when required. This individual is an integral member of project teams to define new instrumentation and integration with PLC or BAS systems, and be part of project startup teams to assist in defining instrument tolerances/accuracies and criticality, installations, initial calibrations, and calibration frequencies. Accountable for electronic entry of calibration data into the Calibration database and ensuring cGMP documentation of instrumentation in the Metrology files ( including but not limited to calibration data sheets, SOP attachments, and logbooks). Responsible for the proper notification to supervisor and departments of any instrument OOT conditions. Essential Functions Perform scheduled calibrations on equipment, instruments and systems in the facility, which include Manufacturing, Packaging, QA, QC, Validation and support areas. Maintain correct and current documentation for all work performed. Knowledge of and proper use of the Metrology database to support completion of activities and documentation of compliance. Collaborate with other functions to ensure Metrology tasks are coordinated into schedules and proactively communicated across departments. Assist with equipment start up and project implementation. Includes participating in impact assessments and assisting with choosing best instruments for our needs. Provide support to Validation function including operating, testing and calibration of equipment and associated system, as well as pre-calibration and post calibration of data logging systems (ie Kaye Validator) Requirements High School diploma or GED required, Certification a plus Minimum of 3 years of instrumentation and field calibration experience; preferably in a pharmaceutical environment. Strong understanding of industrial/pharmaceutical instrumentation and measurement principals, as well as process controls. Ability to read and understand electrical schematics, loop diagrams, and P&IDs. Solid troubleshooting skills; ability to analyze and diagnose instrument failures. Ability to specify new or replacement instrumentation to support new projects or existing processes. Strong understanding of BAS, PLC and distributed control systems GMP and good documentation practices experience Demonstrated ability to work in a team environment Results oriented; high level of initiative and ability to work independently Strong verbal and written communication skills. Experience writing deviations and/or strong technical writing experience Demonstrated ability to effectively multi-task and successfully manage multiple priorities Ability to work independently or with limited supervision Computer skills - Proficiency in Microsoft Office CMMS basic knowledge Working knowledge of Metrology databases Must be able to bend, stoop, crawl and stand for several hours, up to and possibly exceeding 75% time on the job, if necessary to complete work activities. Must be able to walk throughout the site and access all on-site structures. Must be able to repeatedly lift 50 pounds.