3h ago

Senior CSV Engineer

Rome, Italy

$85k-$110k / yearest.

full-timesenior HybridLife Sciences

🛠 Tech Stack

💼 About This Role

You'll lead computer system validation for life sciences clients using GMP and regulatory standards. You'll plan and execute validation of automation, IT, and enterprise systems to ensure compliance. This role offers hybrid work based in Rome with a global professional services firm.

🎯 What You'll Do

  • Prepare/review validation documentation for projects and change controls.
  • Manage change controls and compliance tasks like non-conformances.
  • Analyze testing results and determine acceptability against criteria.
  • Coordinate with departments or vendors to complete validation tasks.

📋 Requirements

  • Experience with computer system validation (CSV) in regulated industries.
  • Knowledge of GMP and regulatory requirements (Part 11/Annex 11).
  • IT delivery experience in manufacturing or integrations.
  • Fluent English communication skills.

✨ Nice to Have

  • Leadership experience in a matrixed environment.
  • Experience delivering enterprise-level IT programs.
  • Italian language skills.

🎁 Benefits & Perks

  • 🌍 Hybrid work model with flexibility.
  • ✈️ Travel opportunities within Italy and Europe.
  • 📈 Professional development and coaching.
  • 🏢 Global company with 800+ employees.
  • 🎯 Impactful work in life sciences.
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