Senior Validation Specialist
2 weeks ago
As a leading provider of operational readiness solutions, CAI is seeking experienced professionals to join our team in a highly evolving field.
With over 800 people worldwide, we have a strong presence globally and provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness to FDA-regulated industries.
Our approach is centered around putting the client's interests first and delivering exceptional results. We live by our Foundational Principles:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
With employee ownership, every individual's success contributes to the team's overall prosperity. We prioritize Team Before Self, demonstrate Respect for Others, and exhibit a can-do attitude.
Key responsibilities include developing and executing protocols and test scripts, identifying gaps, and directing plans for resolution. This entails writing GxP computer validation and 21 CFR Part 11-related documentation, managing change controls, and participating in regulatory audits.
**Requirements:**
- Bachelor's degree in Computer Science or Engineering field or equivalent experience
- Minimum 2-7 years' experience with Computer systems validation
- Minimum 2-7 years' experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483 compliance, as well as deep 21 CFR Part 11 knowledge, is highly desirable
**Other Requirements:**
- Excellent oral and written communication skills in English/Fluent in English
- Able to travel domestically and internationally as required
In return for your skills and knowledge, you will enjoy a wide range of benefits, including opportunities to work on cutting-edge projects, continuing education, and a highly competitive salary.
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