LIMS Solution Architect

New York City , NY : 6 months JOB DESCRIPTION We are seeking a skilled and experienced Solution Architect with a strong background in biopharmaceutical processes and a specialized focus on Laboratory Information Management Systems (LIMS). The ideal candidate will design and implement innovative solutions that enhance laboratory operations, ensuring compliance with regulatory standards and improving data management efficiency. Key Responsibilities: 1. Architectural Design: o Develop and maintain architecture frameworks for LIMS and associated systems. o Collaborate with stakeholders to define system requirements and ensure alignment with business goals. 2. Implementation & Integration: o Lead the implementation of LIMS solutions, ensuring seamless integration with existing laboratory and enterprise systems. o Oversee system configurations, customizations, and data migrations. 3. Stakeholder Collaboration: o Work closely with laboratory managers, IT teams, and regulatory affairs to gather requirements and deliver effective solutions. o Facilitate workshops and discussions to understand user needs and design appropriate solutions. 4. Regulatory Compliance: o Ensure that all LIMS solutions adhere to relevant regulatory standards (e.g., FDA, EMA) and industry best practices. o Conduct risk assessments and implement necessary controls to mitigate compliance risks. 5. Technical Leadership: o Provide technical guidance and mentorship to junior architects and developers. o Stay updated on emerging technologies and industry trends to incorporate into solution design. 6. Documentation & Training: o Develop comprehensive documentation, including system architecture diagrams, user manuals, and training materials. o Conduct training sessions for end-users to ensure effective adoption of LIMS solutions. 7. Performance Monitoring & Optimization: o Establish KPIs to measure the performance of LIMS solutions and drive continuous improvement initiatives. o Troubleshoot and resolve system issues promptly to minimize disruptions in laboratory operations. o Develop and maintain architecture frameworks for LIMS and associated systems. o Collaborate with stakeholders to define system requirements and ensure alignment with business goals. 2. Implementation & Integration: o Lead the implementation of LIMS solutions, ensuring seamless integration with existing laboratory and enterprise systems. o Oversee system configurations, customizations, and data migrations. Technical Proficiency: Database Management: Knowledge of SQL and database design, including relational and NoSQL databases. Programming Languages: Familiarity with languages such as Java, Python, or C# for custom solutions and integrations. System Architecture: Understanding of architectural patterns, including microservices and service-oriented architecture (SOA). LIMS Knowledge: LIMS Functionality: In-depth understanding of laboratory processes and how LIMS supports them, including sample tracking, data management, and compliance. Regulatory Compliance: Familiarity with industry regulations like CLIA, CAP, and FDA guidelines, and how they affect LIMS requirements. Integration Skills: API Development: Experience with RESTful and SOAP APIs for integrating LIMS with other systems (e.g., ERP, MES). Middleware Solutions: Knowledge of integration platforms and middleware tools for seamless data exchange. Project Management: Agile Methodologies: Experience in Agile frameworks (like Scrum or Kanban) to manage LIMS implementation projects. Stakeholder Engagement: Ability to communicate effectively with various stakeholders, including lab staff, IT teams, and management.