We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards.
Key Responsibilities:
- Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.
- Develop and execute validation documentation, including Validation Plans, Requirements, Test Protocols, Traceability Matrix, and Validation Summary Reports.
- Validate AI-enabled systems, including Generative AI, Agentic AI, LLM-based applications, AI agents, and orchestration frameworks.
- Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations.
- Review and approve system testing, UAT scripts, design specifications, and validation deliverables.
- Support audit and inspection readiness activities.
- Collaborate with cross-functional and remote teams to deliver validation projects.
- Provide validation guidance and support multiple projects simultaneously.
Required Skills:
- 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
- Strong experience with SAP ERP (mandatory).
- Experience validating Generative AI, Agentic AI, LLM-based applications, and AI governance.
- Knowledge of GAMP 5, CSA, FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
- Experience in the pharmaceutical, biotechnology, or medical device industry.
- Excellent documentation, analytical, communication, and problem-solving skills.
Flexible work from home options available.
Empowering the Future of Healthcare
The healthcare Industry is on the brink of a paradigm shift where patients are increasingly being viewed as empowered consumers, utilizing digital technologies to better understand and manage their own health. As a result, there is a growing demand for a range of patient-centric services, including personalized care that is tailored to each individual's unique needs, health equity that ensures access to care for all, price transparency to make healthcare more affordable, streamlined prior authorizations for medications, the availability of therapeutic alternatives, health literacy to promote informed decision-making, reduced costs, and many other initiatives designed to improve the patient experience.
ClinDCast is at the forefront of shaping the future of healthcare by partnering with globally recognized healthcare organizations and offering them innovative solutions and expert guidance. Our suite of services is designed to cater to a broad range of needs of healthcare organizations, including healthcare IT innovation, electronic health record (EHR) implementation & optimizations, data conversion, regulatory and quality reporting, enterprise data analytics, FHIR interoperability strategy, payer-to-payer data exchange, and application programming interface (API) strategy.