CSV Engineer

Costa Mesa, CA, US • Posted 60+ days ago • Updated 7 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Job Details

Skills

  • Computer Science
  • Pharmaceutics
  • Biotechnology
  • Life Sciences
  • GxP
  • Good Manufacturing Practice
  • Documentation
  • GAMP
  • Computerized System Validation
  • Technical Writing
  • Attention To Detail
  • Manufacturing
  • LIMS
  • MES
  • SCADA
  • Instrumentation
  • Auditing
  • Management

Summary

Roles & Responsibilities:
  • Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
  • 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
  • Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
  • FDA and cGMP regulations and documentation practices.
  • GAMP 5 guidance.
  • 21 CFR Part 11 and Annex 11.
  • Computer system validation methodologies.
  • Familiarity with risk-based validation execution strategies.
  • Strong technical writing skills with attention to detail.
Preferred Skills:
  • Experience authoring SOPs for laboratory or manufacturing equipment.
  • Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
  • Prior exposure to audits or regulatory inspections.
  • bility to manage multiple projects under tight deadlines.
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: 3239704ea8e5f0580001895ba7c17dce
  • Posted 30+ days ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Remote or Irvine, California

Today

Full-time

USD 94,000.00 - 151,800.00 per year

La Verne, California

Today

Full-time

USD 153,935.00 - 199,210.00 per year

Irvine, California

Today

Full-time

USD 124,700.00 - 205,800.00 per year

Irvine, California

Today

Full-time

Search all similar jobs