CSV Validation Specialist
6 ore fa
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
- 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
- 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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