Labware LIMS Validation Specialist

Job Summary:
Seeking an experienced Lab Ware LIMS Validation Specialist to support validation activities for laboratory systems in a regulated pharmaceutical environment. The role focuses on Computer System Validation, Lab Ware LIMS compliance, and ensuring alignment with GMP, GxP, FDA, 21 CFR Part 11, GAMP 5, and internal quality standards.

Key Responsibilities:

• Execute validation activities for Lab Ware LIMS in compliance with GxP, FDA, and industry regulations.
• Author, review, and execute validation documents including URS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports.
• Collaborate with business, quality, and IT teams to gather and document system requirements.
• Support change controls, deviations, CAPAs, and periodic reviews related to Lab Ware LIMS.
• Ensure compliance with 21 CFR Part 11, GAMP 5, and internal quality standards.
• Participate in system upgrades, enhancements, and remediation activities.
• Provide validation support during audits and inspections.

Skills Required:

• 5+ years of Computer System Validation experience in pharmaceutical or biotechnology environments.
• Hands-on experience validating Lab Ware LIMS applications.
• Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and GAMP 5.
• Experience preparing and executing validation documentation such as URS, IQ, OQ, PQ, Risk Assessments, Traceability Matrix, and Validation Summary Reports.
• Strong understanding of change controls, deviations, CAPAs, and periodic review processes.