ems (CDS), Scientific Data Management Systems (SDMS), and Digital Laboratory Transformation initiatives. The ideal candidate should have strong expertise in Waters Empower 3 CDS, NuGenesis SDMS/ELN, laboratory system administration, validation, and regulated pharmaceutical environments.
The candidate will be responsible for deploying, configuring, administering, and supporting Waters Empower 3 CDS and NuGenesis 9 SDMS/ELN platforms across global laboratory environments. The role includes system installation and configuration, chromatography instrument integration, laboratory workflow customization, user and security management, system upgrades, patch management, troubleshooting, and production support while ensuring compliance with regulatory standards.
Professionals should have hands-on experience with Waters Empower 3 CDS, NuGenesis SDMS, NuGenesis ELN, HPLC, UPLC, GC instrument integration, laboratory workflow configuration, file capture, print capture templates, user administration, security management, validation activities (IQ, OQ, PQ), and enterprise system integration. Strong knowledge of GxP, FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+ Data Integrity principles, SOP creation, change control, and laboratory compliance is highly preferred.
The role also involves collaborating with laboratory scientists, quality assurance teams, IT administrators, validation teams, and global business stakeholders to deliver reliable laboratory informatics solutions. Candidates will support enterprise laboratory transformation initiatives, perform root cause analysis, prepare technical documentation, manage incidents, and ensure high system availability. Strong analytical, communication, stakeholder management, and problem-solving skills are essential.
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