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Metrology Engineer

Company: Exela Pharma Sciences
Location: Lenoir
Posted on: March 18, 2023

Job Description:

Position Summary

Perform routine calibration of Exela equipment. Calibration may include temperature, relative humidity, gas, voltage, pressure, time, rotation, dimensional, balance/scale, conductivity, mass air flow etc. following documented procedures using precision standards. Create, modify and execute calibration procedures/work instructions and calibration certificates. Analyze and determine calibration specifications based on process tolerances. Perform testing and gather data to support the quality management system and reports, troubleshoot and make recommendations about quality issues relating to calibration.

Essential Duties and Responsibilities:

  • Provide support to manufacturing and design areas in development of appropriate measurement methods, including implementing of new methods, analyzing existing measurement methods, and executing training as required.
  • Lead, develop and support measurement methods in compliance with quality regulations (ISO 9001, ISO 13485, 21 CFR Part 820 GMPs)
  • CMMS Measurement Data Template build, review, and approval
  • Create, maintain, and where necessary, optimize tool recipes, working with Engineering and Operations to understand requirements
  • Support additional, non-standard metrology requests as part of product development and root cause investigations (i.e. disposition lot with OOS measurements or lots where measurements have failed)
  • Perform Repeatability, reproducibility and comparison studies
  • Administration of equipment calibration and program maintenance
  • Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules. Knowledge, Skills, Abilities
    • Strong instrumentation and field calibration experience
    • Proficient use of Asset Management System and Quality Systems
    • Strong understanding of industrial instrumentation and measurement principals, as well as process controls
      • Ability to read and understand electrical schematics, loop diagrams, and P&IDs.
      • Ability to work hours necessary to support shift productions
      • Good troubleshooting skills; ability to analyze and diagnose instrument failures
      • Demonstrates good organizational skills and high attention to details including following good manufacturing practices (CGMPs) and good documentation practices (GDPs)
        • Understanding with GMP/GLP, ISO 9001:2008 and ISO 17025
        • Demonstrated ability to work in a team environment
        • Must have the ability to author/review accurate and effective Standard Operating Procedures or Work Instructions
          • Proficient with Microsoft Office (Word, Excel, PowerPoint, Project)
          • Ability to lift 50 lbs. unassisted Experience Requirements
            • Minimum of 4+ years of calibration experience; preferably in a pharmaceutical environment.
            • PMEL, ISA or ASQ training preferred.
              Education Requirements

              Bachelor's Degree in Engineering

              All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Keywords: Exela Pharma Sciences, Gastonia , Metrology Engineer, Engineering , Lenoir, North Carolina

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