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Job Description:
Job Overview:
Platform operations engineer, UDI serve as the critical bridge between AI development and production deployment. While the main developer develops AI functional modules into complete web applications, the platform operations engineer will build and maintain the unified platform that enables application onboarding, version management, user access control, and multi-tenant operations, ensure that function departments can access AI tools securely, stably, and in full compliance with regulatory requirements.
Job Duties and Responsibilities:
The duties may include but are not limited to those listed below:
Platform Engineering & Operations
- Architect and maintain a unified AI application platform supporting modular onboarding, version control, canary releases, and rollback capabilities
- Implement multi-tenant SaaS infrastructure with organizational/team isolation, role-based access control (RBAC), and SSO integration
- Manage production deployment, monitoring, alerting, log aggregation, and incident response
- Optimize cloud resource allocation to balance performance and budget constraints
GxP Compliance & Validation
- Ensure all platform infrastructure and deployment processes comply with GxP requirements (GMP, GCP, GLP as applicable)
- Develop and maintain validation documentation: IQ/OQ/PQ protocols, risk assessments, and traceability matrices
- Implement audit trails, data integrity controls (ALCOA+ principles), and electronic signature workflows for regulated environments
- Support regulatory inspections and audits by providing technical documentation and system evidence
- Establish change control procedures that align with pharmaceutical industry standards
Infrastructure & AI Resource Management
- Maintain stable operation of on-premise AI server deployment and associated GPU infrastructure
- Manage API quotas, enterprise licenses, and technical integration for AI services
- Design CI/CD pipelines that incorporate compliance gates and automated testing
Cross-functional Collaboration
- Provide technical support to business line AI Champions for smooth application delivery
- Develop operational documentation and training materials to lower adoption barriers
Supervisory Responsibilities:
No supervisory responsibilities.
Job Requirements:
o Bachelor's degree in Computer Science, Engineering, or related field
o 2+ years of experience in platform engineering, DevOps, or backend development within regulated industries (pharmaceutical, medical devices, or clinical research preferred)
o Hands-on experience with containerized deployment (Docker/Kubernetes) and major cloud platforms
o Proven ability to own full product lifecycle — from specification to deployment — leveraging AI coding tools (Claude Code, Codex, TRAE, etc.) as primary development interface.
o Solid understanding of identity management and access control (OAuth2, LDAP, SSO) with practical multi-tenant implementation experience
o Proficiency in Linux system administration, network configuration, and database operations (MySQL, PostgreSQL, or MongoDB)
o Demonstrated knowledge of GxP requirements and computer system validation (CSV) in pharmaceutical/clinical research environments
o Ability to work remotely
o Ability to navigate ambiguous requirements and translate them into technical solutions independently
o Strong commitment to platform excellence, balancing developer experience with system reliability
o Comfortable with fast-paced, early-stage department dynamics and wearing multiple hats
o Meticulous attention to detail and documentation quality essential for regulatory compliance
