Takeda Pharmaceutical Company Limited logo

Principal Engineer & Support Manager, DD&T Laboratory Systems (LabWare & MODA)

Takeda Pharmaceutical Company Limited
NewPosted today

LOCATION

Bengaluru · Hybrid

EXPERIENCE

5+ Years

TYPE

FullTime

SKILLS REQUIRED

Technical LeadershipRegulatory ComplianceComputer System ValidationLaboratory Informatics

Job description

Overview

Principal Engineer & Support Manager responsible for strategic leadership, technical stewardship, operational excellence, and continuous improvement of Takeda's LabWare LIMS and MODA platform and associated laboratory informatics ecosystem.

What you'll do

  • Serve as the principal technical authority for the LabWare LIMS and MODA platform.
  • Define and maintain the LabWare and MODA technology roadmap aligned with DD&T and business objectives.
  • Lead solution architecture, platform modernization, and integration strategy.
  • Provide guidance on configuration, customization, workflow design, and best practices.
  • Evaluate emerging technologies and laboratory informatics solutions.
  • Establish and enforce engineering standards, design principles, and technical governance.
  • Own the overall health, performance, scalability, and reliability of the LabWare ecosystem.
  • Ensure platform lifecycle management, including upgrades, patches, and technology refresh activities.
  • Oversee integrations with SAP MES platforms, CDS systems, ELN solutions, data lakes and analytics platforms, and laboratory instruments.
  • Manage technical debt and platform optimization initiatives.
  • Lead global support operations for LabWare and MODA systems.
  • Establish and monitor service performance against agreed SLAs and KPIs.
  • Manage incident, problem, change, and release processes aligned with ITIL principles.
  • Drive root cause analysis and continual service improvement activities.
  • Ensure effective vendor and managed-service-provider performance.
  • Coordinate major incident management and escalation procedures.
  • Ensure systems remain compliant with GxP regulations, FDA 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, and Takeda Quality Management standards.
  • Support audits, inspections, and regulatory inquiries.
  • Review and approve validation documentation including URS, FS, DS, IQ/OQ/PQ, and risk assessments.
  • Ensure adherence to Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies.
  • Lead and develop internal engineers, support analysts, and external partners.
  • Build high-performing global teams through coaching and mentoring.
  • Define team objectives, staffing strategies, and capability development plans.
  • Foster a culture of accountability, collaboration, innovation, and continuous improvement.
  • Support succession planning and talent development activities.
  • Act as trusted advisor to laboratory, quality, manufacturing, and R&D stakeholders.
  • Partner with business process owners to identify digital transformation opportunities.
  • Translate business requirements into scalable technical solutions.
  • Manage stakeholder expectations and communicate platform strategy effectively.
  • Present technical recommendations to senior leadership and governance boards.
  • Ensure compliance with Takeda cybersecurity standards and collaborate with Security and Infrastructure teams on vulnerability remediation.
  • Conduct risk assessments and mitigation planning.
  • Ensure systems maintain high availability, resilience, and disaster recovery readiness.
  • Manage operational and project budgets.
  • Drive value realization from technology investments.
  • Oversee vendor contracts, licensing, and support agreements.
  • Evaluate supplier performance and strategic partnerships.

What you'll need

  • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or related discipline.
  • 5+ years of experience in IT, engineering, or laboratory informatics.
  • 4+ years supporting or engineering LabWare LIMS solutions.
  • 4+ years in technical leadership or management roles.
  • Experience within pharmaceutical, biotechnology, or regulated manufacturing industries.
  • Demonstrated experience managing global support organizations.
  • Proven experience delivering enterprise-scale digital solutions.
  • Strong experience with LabWare LIMS, MODA, Oracle / SQL databases, web services and API integrations, ITIL service management processes, GxP regulated environments, and Computer System Validation (CSV).
  • Experience with cloud and hybrid architecture concepts and DevOps and Agile delivery methodologies.

Nice to have

  • Master's degree in relevant field.
  • LabWare ELN experience.
  • SAP integrations experience.
  • Azure cloud technologies experience.
  • Laboratory instrument connectivity experience.
  • Data analytics platforms experience.
  • CSA methodologies experience.

Details

  • Location: Bengaluru, India.
  • Work mode: Hybrid (flexible work environment, including hybrid working).
  • Employment type: Full time, regular employee.

Read the full description and apply on the company’s own careers page.

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Principal Engineer & Support Manager, DD&T Laboratory Systems (LabWare & MODA)