CSV Validation Specialist

6 ore fa


Bologna, Emilia-Romagna, Italia Cagents A tempo pieno
Job Title: CSV Validation Specialist

We are seeking a skilled CSV Validation Specialist to join our team at Cagents. As a CSV Validation Specialist, you will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.

Key Responsibilities:
  • Develop and execute protocols and test scripts
  • Identify gaps and consult on plans for resolution
  • Write GxP computer validation and 21 CFR Part 11 related documentation
  • Assess and plan for resolution of system issues
Requirements:
  • BS in Computer Science or Engineering field or equivalent experience
  • 2-7 years' experience with Computer systems validation
  • 2 years' experience working in a GMP environment
  • Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
  • Experience in biotech and pharma is preferred over medical device
  • Experience with MES, Delta V, PI is a plus
What We Offer:
  • Comprehensive Health Insurance coverage aligned with local region regulations
  • Paid Time Off
  • ESOP/401K – 15% Company Contribution (US Only)
  • 15% Company Pension Contribution (Europe and APAC Regions)
  • Company Paid Life Assurance
  • Company Paid Income Protection/Long-Term Disability
  • Career/Professional Development Opportunities

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