QC Lab CSV Liz Abbvie

We are seeking a skilled Lab IT & Equipment Support Analyst to provide endtoend support for QC laboratory systems and equipment. The role combines Computer System Validation (CSV) IT system administration and handson lab equipment support ensuring compliance with GxP standards and smooth QC operations

• Administer and support QC Lab IT systems (Empower LIMS ELN EMS and other GxPcompliant applications).
• Provide technical support for laboratory equipment including installation configuration troubleshooting calibration and preventive maintenance.
• Execute CSV activities (IQ/OQ/PQ test planning execution and documentation) for lab systems and benchtop instruments.
• Manage user access roles and Active Directory accounts in compliance with audit requirements.
• Collaborate with QA QC Validation and Engineering teams to ensure operational readiness and compliance.
• Support regulatory audits (FDA 21 CFR Part 11 EU Annex 11 NPRA ISO) and maintain accurate SOPs configuration specifications and validation reports.
• Conduct incident troubleshooting and root cause analysis for both IT systems and lab equipment.
• Provide enduser training on lab IT systems CSV procedures and equipment usage.
• Track and manage software licenses patches updates and IT asset inventory.

• Strong knowledge of GxP FDA 21 CFR 11 EU Annex 11 and GAMP5 compliance.
• Handson experience with QC lab equipment support and IT system administration.
• Proficiency in CSV execution documentation and performance qualification.
• Familiarity with development methodologies (Waterfall Agile).
• Analytical thinking attention to detail and strong problemsolving skills.
• Excellent communication and collaboration across crossfunctional teams.