Cons, IT-Tech Lead QA RA

Job Description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, 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 LabVantages 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, Technical Expertise Required Skills & Qualifications: 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, Bachelors or Masters 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, Dot 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, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,