Posted:2 months ago| Platform:
Work from Office
Full Time
Technical Lead - LabVantage LIMS Location: India (Remote/Hybrid) Company Overview: Vantive is a leading MedTech company specializing in vital organ therapy innovations. Our Quality and Regulatory IT team supports 18 manufacturing plants and corporate QMS operations globally, ensuring compliance with regulatory authorities such as the FDA . We are looking for a Technical Lead - LabVantage LIMS to provide expert-level support for our on-premise EC2-hosted LabVantage LIMS system. The candidate will play a key role in the lift-and-shift migration from Baxter to Vantive , system configuration, troubleshooting, and ongoing enhancements. Key Responsibilities: System Administration Support: Manage and maintain the LabVantage LIMS environment hosted on on-prem EC2 infrastructure . Troubleshoot application, database, and infrastructure-related issues . Monitor system performance and ensure uptime. Configuration Customization: Configure workflows, rules, and business logic within LabVantage. Develop and maintain LIMS Master Data , sample management, and reporting configurations. Implement barcode scanning, instrument integration, and audit trail configurations . Integration Automation: Support integration with external systems , such as ERP, MES, and regulatory submission tools. Work with SQL, Java, and LabVantage s proprietary scripting tools for automation and customizations. Assist in the transition to AWS cloud-based solutions in the future roadmap. Validation Compliance: Ensure 21 CFR Part 11, GxP, and FDA compliance. Prepare validation documentation, test scripts, and change control processes. Support periodic audits and system reviews. Project Management Stakeholder Engagement: Work closely with global IT teams, business users, and vendors to gather requirements and deliver solutions. Collaborate with quality, regulatory, and lab operations teams to enhance system usability. Drive technical roadmap and enhancements for LabVantage at Vantive. Required Skills Qualifications: Technical Expertise: LabVantage LIMS (Version 8.x or higher) - 5+ years of hands-on experience On-Prem EC2 Hosting - Familiarity with managing applications on AWS EC2 Java, JBoss, and Web Services - Experience in LIMS scripting, API development, and integrations SQL Oracle DB - Writing and optimizing queries, database administration experience Workflow Configuration Master Data Management - Setting up lab workflows, security roles, and user access GxP, 21 CFR Part 11 Compliance - Experience in validated environments Lab Equipment Barcode Integration - Experience integrating LIMS with lab instruments Soft Skills Leadership: Strong problem-solving troubleshooting skills Ability to lead technical discussions mentor junior team members Excellent communication stakeholder engagement skills Experience with ITIL frameworks, change management, and incident handling Preferred Skills (Nice to Have): Experience with AWS cloud migration strategies Exposure to Veeva QMS, TrackWise, or other Quality Regulatory IT systems Prior experience in Medical Device or Pharma industries Qualifications Experience Must-Have Qualifications 5+ years of experience working with LabVantage LIMS in a technical support/configuration role. Strong knowledge of LIMS system administration, workflows, and master data setup. Proficiency in JavaScript, Groovy scripting, or Python for system customization. Hands-on experience with API integrations (REST/SOAP) and enterprise system connectivity. Strong knowledge of AWS including cloud security, deployment, and infrastructure management, Windows/Linux servers, and infrastructure best practices. Ability to troubleshoot complex technical issues and implement effective solutions. Excellent communication and collaboration skills, with experience working in cross-functional teams. Experience in pharmaceutical, biotech, or medical device industries preferred. Bachelor s or Master s degree in Computer Science, Information Systems, or a related field. Preferred Qualifications Familiarity with GxP, FDA regulations, CSV (Computer System Validation), and change control processes. Experience with SQL, .NET, Java, or scripting languages for system troubleshooting and automation. Familiarity with ITSM tools (e.g., ServiceNow) and Agile methodologies. Certifications in AWS is a plus. Basic project management experience (Agile, Waterfall, or hybrid methodologies). Strong problem-solving and analytical skills to address complex system issues. Excellent communication and stakeholder management skills . Recruitment Fraud Notice
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