Senior Validation Engineer

Salt Lake City, UT, US • Posted 60+ days ago • Updated 8 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Master Data Management
  • GMP
  • Data Collection
  • Process Engineering
  • Good Manufacturing Practice
  • MES
  • LIMS
  • Communication
  • Documentation

Summary

Roles & Responsibilities :
  • Develop and execute validation strategies
  • Lead Process Validation & PPQ activities
  • Perform C&Q for equipment, utilities, and facility systems
  • Run risk and gap assessments
  • Maintain equipment master data and support change controls
  • Execute floor-level validation in GMP cleanrooms
  • Coordinate sampling and data collection
  • Support recipe authoring, data trending, and automation needs
  • Train and guide cross-functional teams
Education & Experience :
  • Bachelor's in Engineering
  • 5+ years in biopharma validation/process engineering
  • Strong process validation & equipment qualification experience
  • cGMP, FDA/EMA, ICH Q7-Q10 knowledge
  • MES, automation, LIMS exposure
  • Cleanroom and hands-on lab skills
  • Strong communication & documentation abilities
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: e02187bc5ce4fff92d7fb9634995a9d6
  • Posted 30+ days ago
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