CSV Engineer

Hillsboro, OR, US • Posted 60+ days ago • Updated 11 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Communication
  • Manufacturing
  • Computer Science
  • Life Sciences
  • Computerized System Validation
  • GAMP
  • SCADA
  • OSI
  • Siemens
  • Pharmaceutics
  • MES
  • System Administration
  • GMP
  • GxP
  • Data Integrity
  • Risk Assessment

Summary

Job Description:
We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.
Requirements:
  • Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
  • 5+ years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry.
  • Hands-on experience with SCADA, OSI-PI, Siemens_desigo, Rockwell FactoryTalk Pharma Suite, DeltaV, and MES.
  • Experience with system administration and EBR recipe authoring preferred.
  • Strong understanding of ISA-95 model (Level 2 & Level 3 required; Level 1 is a plus).
  • Knowledge of FDA regulations (21 CFR Part 11), Annex 11, EU GMP Annex 1, GxP practices, and Data Integrity principles.
  • Experience performing system and data integrity risk assessments.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 530022d850b9a74d8393fb3610c305b9
  • Posted 30+ days ago
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