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Validation Expert for Life Sciences Systems
Há 1 mês
**About Capgemini Engineering**
We are the world leader in engineering services, bringing together a global team of engineers, scientists, and architects to help companies unleash their potential. Our digital and software technology experts provide unique R&D and engineering services across all industries.
**Your Career Opportunity**
We are seeking a skilled Validation Expert to join our team in the Life Sciences sector. This role is critical in ensuring compliance with regulatory requirements and maintaining the integrity and reliability of computerized systems.
**Responsibilities**
- Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
- Conduct thorough risk assessments and impact analyses.
- Develop and implement effective validation strategies for Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).
- Collaborate with cross-functional teams to ensure seamless system integration and data exchange.
**Requirements**
- Experience in Computer System Validation (CSV) within the Life Sciences industry.
- In-depth knowledge of regulatory requirements and industry standards.
- Strong analytical and problem-solving skills, with the ability to conduct thorough risk assessments and impact analyses.
- Excellent documentation skills and attention to detail.
- Good command of English.
**What We Offer**
- Join a multicultural and inclusive team environment.
- Enjoy a supportive atmosphere promoting work-life balance.
- Hybrid work options.
- Access valuable training and certifications in cutting-edge technologies.
- Engage in exciting national and international projects.
- Health and life insurance.
- Referral program with bonuses for talent recommendations.
**Estimated Salary: $120,000 - $180,000 per year**
