IT Application Architect — Laboratory Information Management System (LIMS) at Edwards Lifesciences Corporation Japan

pune, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

0.0

Posted On

11 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

LIMS, LabWare, LabVantage, 21 CFR Part 11, GxP, Software Development Life Cycle, System Validation, IQ/OQ/SDD, SQL, Relational Databases, Application Architecture, System Integration, Technical Roadmap, Change Management, Problem Management, Regulatory Compliance

Industry

Medical Equipment Manufacturing

Description

Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working in close partnership with teams across regions to deliver reliable, high-quality solutions at scale. Designed as a long-term investment, the Pune Hub will advance newer digital capabilities such as automation, data, AI, and cloud, and will include roles spanning end user services, application development, and enterprise platform teams. Together, these teams will help Edwards operate more efficiently and accelerate innovation in support of our mission of advancing patient care. The IT Application Architect, LIMS, will serve as the technical owner of our enterprise Laboratory Information Management System (LIMS) reporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Application Architect, LIMS, you will be a key member of a global quality technical transformation team implementing and guiding the technical evolution and optimization of LIMS across a global organization. How you’ll make an impact: Design and implement LIMS technical solutions to meet business requirements. Oversee all technical delivery for LIMS and assume technical ownership of the system. Define and implement IT LIMS standards, ensuring alignment with global IT and industry best practices for software development and system implementation. Manage the technical platform roadmap, including regular platform updates and prompt resolution of IT security vulnerabilities within established SLAs. Advocate for remediation of technical debt and continuous system improvements to drive business growth and development. Partner with business leaders to understand organizational needs and assess implementation complexity for both in-house and project-funded initiatives. Act as a steward for LIMS integrity, making informed recommendations to minimize unnecessary customization and preserve system purpose. Execute a shift-left strategy for support and maintenance, transferring Level 2 (L2) support to the global team while retaining Level 3 (L3) support, problem management, and change management within the transformation team. What you’ll need (Required): Bachelor’s degree with 8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise LabWare and/or LabVantage LIMS. Experience working with 21 CFR part 11. Experience working in a regulated environment, and strong understanding of GxP concepts and regulatory compliance in a pharmaceutical/medical device setting. Experience with commercial off the shelf applications and a solid understanding of the importance master data structure plays in a scalable enterprise solution. Experience writing and executing validation deliverables (e.g., IQ/OQ/SDD) in the software development life cycle (SDLC) for validated, regulated, applications. What else we look for (Preferred): Strong background in server-client and/or web hosted application architecture, integrations to applications and equipment; preference for experience with laboratory instruments and enterprise systems (such as ERP and MES). Experience with server administration required to support an enterprise application. Experience with structured query language (SQL) and relational databases. Experience / knowledge with remote desktop and other web hosting platforms. Experience working with application vendors, and 3rd party consulting companies on technology implementations and delivery. Experience working in a global, highly matrixed, and team-oriented IT environment. High energy, self-motivation, and results-driven mindset with an excitement to learn new technologies. Have a passion for our mission at Edwards Lifesciences. Comfortable communicating and presenting ideas/recommendations to a senior leadership level. If you are passionate about advancing laboratory information management, thrive in collaborative global teams, and want to make a significant impact on business and IT transformation, we invite you to apply. #LI-Onsite Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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Responsibilities

The IT Application Architect will serve as the technical owner of the enterprise Laboratory Information Management System (LIMS), overseeing technical delivery and system evolution. They will define IT standards, manage the platform roadmap, and partner with business leaders to ensure system integrity and regulatory compliance.