Quality Engineer

Company: Thermo Fisher Scientific
Location: Allentown
Posted on: February 14, 2020

Job Description:

What will you do? Our company is seeking a Quality Engineer responsible for quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management (temperature, humidity, differential pressure), and oversite of Maximo work order system (calibration, corrective maintenance).This role requires the ability to make decisions that are based on sound quality/compliance principles and appropriate GMP Regulations.How will you get here?Education

• Bachelor's Degree.Responsibilities
  • Apply Good Manufacturing Principles in all areas of responsibility.
  • Demonstrate and promotes the company vision.
  • Review impact analysis of changes to facilities and equipment.
    • Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
    • Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
    • Drives continuous improvement to the site's equipment and facilities qualification/validation program.
    • Assist in the review of site procedures related to equipment and facilities as required
    • Monitor the site's calibration program.
    • Monitor the site's preventative maintenance program.
    • Facilitate, participate, and approve Risk Assessment.
    • Conduct all activities in a safe and efficient manner.
    • Other duties may be assigned to meet business/compliance needs.Knowledge, Skills, Abilities
      • A minimum of 5 years in the pharmaceutical/related regulated industry.
      • Experience with equipment and facilities validation Quality Systems.
      • Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
      • Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
      • Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
      • Good written and verbal communication skills.
      • Thorough understanding of regulatory documentation requirements.
      • Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
      • Ability to work independently.
      • Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
      • Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
      • Experience in Risk Assessment.Physical Requirements
        • This position is administrative and is positioned in an office environment but does require some time in manufacturing, packaging, and computer areas.
        • It requires standing bending reaching, walking and talking as well as exerting up to 20lbs.

Keywords: Thermo Fisher Scientific, Allentown , Quality Engineer, Engineering , Allentown, Pennsylvania