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Process Engineer

We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:

  • Root cause analysis
  • Investigation experience for QN/CAPAclosures
  • Experience with manual and automated systems/lines

Requirements

  • Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
  • Strong experience in the Medical Device industry (required).
  • Pharmaceutical industry experience (preferred).
  • Demonstrated experience with validation life cycle activities (design, execute, analyze, and close protocols/reports).
  • Experience performing root cause analysis and implementing solutions.
  • Experience supporting investigations, QN, and CAPA closures.
  • Experience working with manual and automated manufacturing systems/production lines.
  • Ability to work effectively in a fast-paced manufacturing environment.
  • Standard site schedule; flexible to support 24/7 operation including shifts, weekends, and holidays as operational demands requireBilingual (English and Spanish) required.
  • Availability to work in Texas.

Skills

  • Validation Lifecycle Management
  • Root Cause Analysis
  • CAPA
  • Medical Device Manufacturing
  • Process Engineering
  • GMP
  • Bilingual (English/Spanish)

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