Lab Solutions Support Engineer/GXP Validation
Waltham MA (Onsite)
12+ months Contract
Seeking a Digital Lab Solutions Support Engineer to provide technical and operational support for laboratory informatics systems and connected laboratory instruments within a regulated pharmaceutical environment. The ideal candidate will have strong experience supporting LIMS/ELN/CDS platforms, troubleshooting lab instrument integrations, and maintaining validated systems in compliance with GxP and 21 CFR Part 11 requirements.
Key Responsibilities
Provide day-to-day support for laboratory systems including LIMS, ELN, CDS, Empower, Chromeleon, and related scientific applications.
Troubleshoot issues involving laboratory instruments, middleware, workstations, network connectivity, and data integrations.
Support installation, configuration, validation, and lifecycle management of laboratory instruments and associated software.
Execute and maintain CSV documentation including IQ/OQ/PQ, test scripts, traceability matrices, and change controls.
Collaborate with QA, QC, R&D, Facilities, and IT teams to ensure reliable and compliant lab operations.
Support instrument integrations using APIs, middleware, file transfer mechanisms, and database connectivity.
Perform system patching, antivirus updates, OS hardening, and backup/recovery activities while maintaining validated state compliance.
Manage incidents, changes, and CMDB updates through ServiceNow.
Participate in audit readiness activities and ensure compliance with GxP, ALCOA+, and 21 CFR Part 11 standards.
Coordinate with vendors for troubleshooting, upgrades, maintenance, and qualification activities.
Support lab modernization and automation initiatives across digital laboratory environments.
Required Qualifications
5+ years of experience supporting laboratory systems within pharmaceutical, biotech, or regulated environments.
Hands-on experience with one or more laboratory platforms such as LabWare, LabVantage, STARLIMS, SampleManager, Empower, Chromeleon, or ELN systems.
Strong understanding of GxP, CSV, GAMP5, 21 CFR Part 11, and data integrity requirements.
Experience troubleshooting laboratory instrument connectivity and middleware integrations.
Knowledge of Windows administration, Active Directory, networking basics, and system security controls.
Experience with ServiceNow or similar ITSM tools.
Strong analytical, troubleshooting, and communication skills.
Preferred Qualifications
Experience with scripting/automation using Python, PowerShell, or SQL.
Exposure to cloud-connected lab environments (Azure/AWS).
Familiarity with chromatography systems, analytical instruments, and scientific workflows.
Experience supporting FDA/EMA audit readiness activities.
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