GxP CSV Validation Engineer

As a GxP CSV Validation Engineer at Capgemini Invent, you will play a crucial role in ensuring that digital systems used in clinical development comply with regulatory standards such as GxP, 21 CFR Part 11, and EMA Annex 11. Your responsibilities will include: - Developing and executing validation protocols (IQ, OQ, PQ) for digital systems in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety. - Conducting risk assessments and maintaining documentation to support system compliance and audits. - Ensuring that all digital systems meet the requirements of GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. Qualifications required for this role include: - A Bachelor's or Master's degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field. - Certifications such as Certified Quality Auditor (CQA), GAMP 5, or other CSV-related certifications would be advantageous. At Capgemini, a global business and technology transformation partner, you will be part of a diverse team of 340,000 members across 50 countries. With over 55 years of experience, Capgemini is trusted by clients to deliver end-to-end services and solutions that leverage technology to address a wide range of business needs. The company's expertise in AI, cloud, and data, combined with industry knowledge and a strong partner ecosystem, allows Capgemini to create tangible impact for enterprises and society. In 2023, Capgemini reported global revenues of 22.5 billion. As a GxP CSV Validation Engineer at Capgemini Invent, you will play a crucial role in ensuring that digital systems used in clinical development comply with regulatory standards such as GxP, 21 CFR Part 11, and EMA Annex 11. Your responsibilities will include: - Developing and executing validation protocols (IQ, OQ, PQ) for digital systems in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety. - Conducting risk assessments and maintaining documentation to support system compliance and audits. - Ensuring that all digital systems meet the requirements of GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. Qualifications required for this role include: - A Bachelor's or Master's degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field. - Certifications such as Certified Quality Auditor (CQA), GAMP 5, or other CSV-related certifications would be advantageous. At Capgemini, a global business and technology transformation partner, you will be part of a diverse team of 340,000 members across 50 countries. With over 55 years of experience, Capgemini is trusted by clients to deliver end-to-end services and solutions that leverage technology to address a wide range of business needs. The company's expertise in AI, cloud, and data, combined with industry knowledge and a strong partner ecosystem, allows Capgemini to create tangible impact for enterprises and society. In 2023, Capgemini reported global revenues of 22.5 billion.