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Capgemini Engineering is seeking an experienced LIMS Solution Architect to lead laboratory digitalization and quality transformation for Life Sciences clients in Bengaluru. The role demands strong design, integration, and validation skills within regulated GxP environments.
You will drive end-to-end LIMS implementations, align requirements with GMP/FDA standards, and mentor project teams while collaborating with Quality, R&D, Manufacturing and IT stakeholders.
We are seeking an experienced LIMS Solution Architect with expertise in LabVantage and/or LabWare to lead laboratory digitalization and quality transformation initiatives for Life Sciences clients. The ideal candidate will have strong experience in LIMS design, implementation, integration, and validation within regulated GxP environments.
Lead end-to-end LIMS solution architecture and implementation using LabVantage and/or LabWare.
Gather business requirements and translate them into scalable laboratory solutions.
Design and configure workflows for sample management, testing, stability studies, specifications, and laboratory execution.
Integrate LIMS with ERP, MES, ELN, CDS, SDMS, and laboratory instruments.
Ensure compliance with GMP, GLP, GAMP5, FDA 21 CFR Part 11, and data integrity requirements.
Lead validation, deployment, migration, and go-live activities.
Collaborate with Quality, R&D, Manufacturing, and IT stakeholders.
Provide technical leadership, architecture governance, and mentoring to project teams.
8–10 years of experience in LIMS, Laboratory Informatics, or Life Sciences IT.
Hands-on experience with LabVantage and/or LabWare LIMS.
Strong understanding of laboratory operations, sample lifecycle, and quality processes.
Experience with system integrations, SQL, APIs, reporting, and data migration.
Knowledge of CSV (Computer System Validation), GxP, ALCOA+, and regulatory compliance requirements.
Familiarity with Life Sciences digital transformation and Industry 4.0 initiatives.
Bachelor's/Master's degree in Life Sciences, Engineering, Computer Science, or related field.
Experience working with pharmaceutical, biotechnology, or medical device organizations.
Relevant LabVantage/LabWare certifications preferred.
Strong communication, stakeholder management, and consulting skills.