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Validation Engineer (CSV)


Requisition Number: P12117

Region: US
State: Wisconsin
City: Eau Claire, Hudson, or Menomonie

Responsibilities

  • Computerized system validation (CSV) support for global compliance and facility expansion.  Serialization validation support and other project validation support for pre-production billable customer projects.
  • 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 in a manufacturing environment.

Qualifications - Skills & Competencies

  • Strong and diverse validation skills
  • Cloud systems GxP validation; Multi-system CSV; Medical product packaging validation including GS1, UDI, SSCC and Serialization; Data historian validation
  • 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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