Senior Lab Systems Engineer

Overview

Support the implementation, configuration, integration, validation, and operation of laboratory systems for the Manufacturing & Quality organization, primarily NuGenesis SDMS/ELN and Empower CDS. The role supports laboratory operations, system integrations, automation, digital initiatives, data integrity, and regulatory compliance under the supervision of senior team members.

What you'll do

• Support installation, deployment, and configuration of NuGenesis SDMS and Empower CDS systems, including integration with other systems and platforms.
• Deliver systems integration and designs.
• Analyze, triage, and resolve Lab Systems incidents using tools such as ServiceNow, JIRA, or ALM.
• Coordinate system validation activities, including preparation and execution of IQ/OQ/PQ protocols, test scripts, and validation documentation.
• Support CAPA processes for CDS/SDMS-related incidents by documenting root causes and corrective actions and working toward closure.
• Configure and maintain lab system settings, user access, instrument methods, and project structures.
• Collaborate with multifunctional teams to support system operations.
• Prepare and maintain SOPs, user documentation, and knowledge articles.
• Mentor junior team members in architecture design, system development, deployment, and troubleshooting.
• Assist in configuring instrument integrations for chromatography systems connected to Empower to ensure accurate data acquisition and transfer.
• Enable integration tasks across CDS, SDMS, and LIMS systems using defined configurations and middleware setups.
• Assist with LAC/E instrumentation support and system project/method configurations as required.
• Implement validation by writing and running test scripts and protocols and maintaining supporting validation documentation.
• Ensure activities are performed and documented in compliance with GMP regulations, including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
• Support CAPA management for NuGenesis and Empower-related incidents.
• Maintain GMP/GxP/CSV compliance documentation, including build specifications, configuration specifications, and SOPs.
• Represent the team in change-control activities and periodic system review processes.
• Work with senior analysts, lab teams, QA, and IT SMEs to support day-to-day NuGenesis and Empower operations.
• Follow standards, templates, and procedures defined by global governance frameworks.
• Develop the Lab system knowledge base through documentation updates, knowledge articles, and SOP revisions.

What you'll need

• Bachelor's or equivalent degree in Computer Science, Instrumentation, Chemical Engineering, Analytical Chemistry, or a related field.
• 15+ years of experience in laboratory informatics or CDS/SDMS support, preferably in the pharma, biotech, or chemicals industry.
• Hands-on experience with NuGenesis SDMS and/or Empower CDS and other lab systems deployment and support.
• Good experience in GMP-regulated environments with understanding of compliance, data integrity, and validation standards.
• Experience handling incidents and driving CAPA processes in a regulated laboratory environment.
• Familiarity with system validation practices, including CSV/SDLC.
• Good experience or strong working knowledge of NuGenesis SDMS and/or Empower CDS, including support and deployment experience across either or both platforms.
• Experience developing system architecture with scalability and maintenance.
• Experience supporting deployment and installation activities for NuGenesis SDMS or Empower CDS.
• Experience analyzing and resolving incidents for lab systems.
• Practical experience performing system validation activities in a GMP-regulated environment.
• Experience supporting CAPA processes, including documentation and corrective-action follow-through.
• Ability to write and maintain user documentation and SOPs.
• Good communication and analytical skills.

Nice to have

• Certification on any Lab or CDS Solution.
• Exposure to LabVantage LIMS or SmartLab platforms.
• Familiarity with other LIMS or lab informatics platforms, such as LabWare or StarLIMS Darwin LIMS.
• Basic SQL and database knowledge for data integrity queries and system support.
• Knowledge of reporting technologies such as Jasper Reports or Crystal Reports.
• Basic understanding of ETL/middleware tools, including MuleSoft, Boomi, or Talend.
• Exposure to data analytics or digital lab transformation projects.
• Familiarity with chromatography instrument integrations and Empower project/method configuration.

Details

• Location: Hyderabad, India.