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CSV Validation Specialist

2 mesi fa

Bologna, Emilia-Romagna, Italia Cagents A tempo pieno
About Cagents

Cagents is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management, and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.

Position Description:

The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Key Responsibilities:
  1. Develop and execute protocols and test scripts to ensure computer systems meet regulatory requirements
  2. Identify gaps in computer systems and develop plans for resolution
  3. Consult on and direct plans for resolution to ensure compliance with regulatory requirements
  4. Write GxP computer validation and 21 CFR Part 11 related documentation
Requirements:
  1. BS in a Computer Science or Engineering field or equivalent experience
  2. 2-7 years' experience with Computer systems validation
  3. 2 years' experience working in a GMP environment
  4. Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
  5. Experience in biotech and pharma is preferred over medical device
  6. 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
  • Additional benefits/leave entitlements based on local regional requirements.