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Quality Validation Engineer


Requisition Number: P12057

Region: US
State: Wisconsin
City: Menomonie

Responsibilities

  • Coordinate, direct and lead validation efforts including: 
  • -Process
  • -Computer System Validation including Electronic Records & Electronic Signature Assessments, Risk Assessment, Supplier Assessment
  • -Equipment and Instrumentation Qualification 
  • -Facility and Utility Qualification 
  • Compile and analyze validation data, write/review/approve protocols, reports, and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.
  • Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and processes and support change management.
  • Functions as a liaison with project engineering, manufacturing and the customer regarding validation
  • Interface with customers on a regular basis to resolve issues
  • Some programs may have vision requirements
  • Extended travel may be required to other facilities to support business needs
  • Other duties as assigned

Qualifications - Education & Experience

  • B.S. degree in engineering field with related experience in engineering and process validation

Qualifications - Skills & Competencies

  • Strong and diverse validation skills
  • Strong knowledge of Statistical Process Control 
  • Ability to manage multiple large-scale projects
  • Demonstrated superior communication, teamwork and organizational skills
  • Ability to develop and meet project schedules, along with contingency plans
  • Demonstrated ability to think out of the box and recommend options
  • Demonstrated broad understanding of capabilities and technologies of other PPC facilities, suppliers, and customers
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers
  • Strong communication (verbal and written), teamwork and organizational skills

 

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