Laboratory System Solutions and Support Engineer

We are seeking an experienced Laboratory System Solutions and Support Engineer for Pharmaceutical Laboratory Systems, specializing in laboratory instruments, instrument connectivity, data integration, and laboratory application ecosystems. The ideal candidate will combine strong hands-on experience supporting laboratory instruments and systems with the technical architecture expertise required to troubleshoot and implement integrations between laboratory equipment and applications such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and Scientific Data Management Systems (SDMS). The role covers a broad range of laboratory instrumentation, from simple analytical devices such as balances, pH meters, and titrators to complex analytical platforms such as Chromatography Data Systems (CDS), Mass Spectrometry (MassSpec) systems, and associated laboratory software. The successful candidate will serve as the technical authority for instrument connectivity, data acquisition, data flow, interface design, and troubleshooting across pharmaceutical laboratory environments. They will work closely with laboratory users, QC and analytical teams, IT, automation, CSV/CSA, infrastructure, cybersecurity, and application teams to ensure reliable, secure, compliant, and fit-for-purpose laboratory operations.

Responsibilities

1. Laboratory Instrumentation Expertise

• Act as the SME for a broad portfolio of pharmaceutical laboratory instruments, including:
• Basic to intermediate instruments:
• Analytical and precision balances, pH meters, conductivity meters, titrators, moisture analyzers, dissolution testers, and similar laboratory equipment.
• Advanced analytical instruments:
• HPLC, UPLC, GC, ion chromatography, and associated Chromatography Data Systems (CDS).
• Complex analytical platforms:
• Mass Spectrometry (LC-MS/MS, GC-MS), spectroscopic instruments, and other advanced analytical systems.
• Understand instrument operating principles, software architecture, data acquisition mechanisms, and connectivity capabilities.
• Assess instrument capabilities, vendor software, communication protocols, drivers, and interface requirements.
• Support instrument onboarding, installation, configuration, qualification, troubleshooting, upgrades, and lifecycle management.

2. Instrument Connectivity and Integration Architecture

• Design and document end-to-end connectivity architectures between laboratory instruments and laboratory applications.
• Understand instrument connectivity mechanisms, including:
• Serial communication (RS-232/RS-485), USB, Ethernet, and TCP/IP.
• Vendor-specific drivers, middleware, APIs, SDKs, and integration utilities.
• Shared folders, network file transfers, database interfaces, and message-based integrations.
• Direct instrument-to-application connectivity and intermediary acquisition or integration platforms.
• Evaluate how instruments connect to workstations, instrument controllers, laboratory networks, application servers, and enterprise systems.
• Define appropriate connectivity patterns based on instrument capabilities, vendor constraints, data integrity, security, and business requirements.
• Identify and resolve connectivity bottlenecks, communication failures, driver issues, and interface incompatibilities.

3. Integration with Laboratory Applications

Work with application development team to provide support for instrument interfaces including:

• Sample management, test assignments, results transfer, and laboratory workflows.
• Experimental data capture, calculations, observations, and electronic documentation.
• Scientific data collection, indexing, storage, retrieval, and contextualization
• Work with application vendors and internal IT teams to implement, test, and maintain reliable interfaces.
• Troubleshoot end-to-end integration issues across instruments, middleware, networks, databases, and consuming applications.

4. Hands-on Support and Technical Troubleshooting

• Provide hands-on L2/L3 or equivalent specialist support for laboratory instruments, acquisition software, and connected laboratory applications.
• Investigate incidents involving instrument communication, software configuration, failed data transfers, missing results, corrupted or inaccessible files, and application connectivity.
• Perform root-cause analysis and implement corrective and preventive actions.
• Support laboratory users during critical testing activities and instrument-related incidents.
• Coordinate with instrument manufacturers, software vendors, service providers, and internal support teams to resolve complex technical issues.
• Participate in incident, problem, and change management processes and contribute to knowledge articles, SOPs, and support documentation.
• Provide technical guidance during instrument moves, additions, upgrades, replacements, and decommissioning.

5. Pharmaceutical Compliance and Data Integrity

• Ensure that instrument connectivity and integration solutions align with applicable pharmaceutical GxP requirements and organizational quality standards.
• Apply knowledge of relevant regulatory and industry expectations, including:
• FDA 21 CFR Part 11, where applicable.
• EU GMP Annex 11, where applicable.
• ALCOA+ data integrity principles.
• Good Documentation Practices and electronic record management.
• Support requirements definition, risk assessments, traceability, testing, qualification, and validation activities for instrument interfaces and laboratory systems.
• Collaborate with Quality Assurance and CSV/CSA teams to establish appropriate controls for audit trails, access management, data retention, backup, recovery, and electronic signatures.
• Ensure that technical solutions support reliable, traceable, and compliant handling of laboratory data.

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