Remote - Lab Informatics and Empower System Administrator
Job Title: Lab Informatics and Empower System Administrator Location: Manhattan, NY Duration: 9 Months Position Summary: The Lab Informatics Administrator is responsible for the technical administration, master data management, and instrument connectivity of laboratory systems, primarily focusing on Empower 3 CDS and LIMS (e.g., LabVantage). This role ensures data integrity, compliance with 21 CFR Part 11, and seamless integration between laboratory instruments and informatics platforms. Key Responsibilities Empower CDS Administration & Master Data: Act as a Subject Matter Expert (SME) for Empower 3 CDS architecture, project structures, user roles, and security policies. Design, implement, and maintain master data frameworks, including standardized processing methods, instrument types, and sample templates. Perform master data migration, cleansing, and consolidation activities to ensure global standardization. Configure custom fields and audit trail reviews to ensure data integrity. Instrument Connectivity & Integration: Manage laboratory instrument connectivity (HPLC, UPLC, GC, LC-MS) to Empower 3 CDS and LIMS using NuGenesis SDMS or similar middleware. Troubleshoot acquisition and networking connectivity issues between instruments and servers. Configure and maintain instrument drivers (ICS), firmware updates, and PC interfaces. Lab Master Data Management (LIMS): Create, revise, and maintain master data in LIMS systems, including test methods, specifications, parameters, and product data. Support new product setups and troubleshoot master data functional issues. Compliance & Validation: Support system validation efforts (CSV) for software upgrades, enhancements, and new site implementations (IQ/OQ/PQ). Develop SOPs, work instructions, and data standards to ensure compliance with GxP, GLP, and FDA 21 CFR Part 11. Coordinate with IT for server maintenance, backup, and security patching. Required Knowledge, Skills, and Abilities Technical Expertise: Strong hands-on experience with Waters Empower 3 CDS (configuration, custom fields, project creation) and LIMS platforms (LabVantage, LabWare, or similar). Instrument Connectivity: Solid understanding of chromatography systems (HPLC/LCMS) and networking concepts. Regulatory Knowledge: Deep understanding of GxP compliance, data integrity principles, and 21 CFR Part 11 requirements. Data Management: Excellent attention to detail for managing complex data sets and troubleshooting system errors. Education and Experience Bachelor s degree in Chemistry, Analytical Chemistry, Information Technology, or related science field. 3 7 years of experience in laboratory IT support, CDS administration, or laboratory data management, preferably in the pharmaceutical industry.