Takeda is inviting applications for the role of Quality Systems Engineer Laboratory Systems in Bengaluru. This opportunity is part of the Quality Assurance function and focuses on laboratory instrument connectivity systems, including Chromeleon and Empower, for QC lab systems.

The selected candidate will work as part of the QC Lab Connect team and support global laboratory system solutions by bridging business needs with technology solutions.

Job Details

Job Description

The Quality Systems Engineer Laboratory Systems will be a member of the QC Lab Connect team and will manage projects and initiatives focused on laboratory instrument connectivity systems such as Chromeleon and Empower.

The role involves enabling Takeda QC Labs with global solutions, specifically Empower and Chromeleon, as per the global lab systems roadmap. The DDT Quality Systems Engineer Lab Systems acts as a bridge between business needs and technology solutions, helping analyse, transform and resolve business problems through efficient use of technology.

The position includes end-to-end solution engineering across requirements, design, build/configuration, testing/UAT and release. The role also involves limited-supervision work, technical leadership for complex IT systems and projects, and support of DDT systems owned by the group. The candidate will also be part of the on-call support team once training is complete.

Key Responsibilities

• Understand and analyze requirements for Chromatography instrumentation especially using knowledge of Empower and Chromeleon systems to implement solutions.
• Work with the Takeda laboratories to help them understand their requirements around workflows such as Environmental Monitoring, Raw Materials receiving and inspection, Standards and reagent management and testing, Lot/batch QC testing and release, stability testing of products, and test instrument management.
• Assess proposed solutions to help stakeholders select the solution that best fits their requirements.
• Plan tasks and activities for Business Analysis, including stakeholder analysis, managing issues, risks and requirements, and monitoring and reporting on business analysis activities.
• Oversee and participate in architectural design, development, customization and integration efforts.
• Provide oversight of vendor-provided solutions and handle ad-hoc technical requests from both internal and external partners.

Qualification

• Bachelor’s degree preferred or relevant work experience in systems or business.
• Technical troubleshooting skills related to chromatography systems, including windows operating systems, DCOM, active directory, firewalls, etc.
• Well-developed organizational skills and the ability to manage multiple projects simultaneously.
• Ability to interact with stakeholders in multiple parts of the globe.
• Ability to effectively interact with multifunctional teams, including Infrastructure, Quality Assurance, Validation, and Quality Control laboratory stakeholders.
• Self-motivated and self-directed approach to driving results and deliverables.
• GxP/CSV validation delivery for lab systems, including 21 CFR Part 11, EU Annex 11, data integrity/ALCOA+, and audit readiness.
• Ability to write and speak in the English language.
• Technical/Functional expertise.
• Incident/problem management for lab-critical systems, including triage, root cause, CAPA, vendor escalation, and on-call readiness.

Preferred Knowledge and Skills

• Knowledge of testing tools such as MicroFocus ALM.
• Working knowledge of troubleshooting, administering, and deploying chromatography systems Empower and/or Chromeleon is an advantage.
• Knowledge of support tools such as ServiceNow.
• Previous experience or interactions with application vendors such as Waters and Thermo is an advantage.
• Working knowledge of Change Management.
• Ability to gather, understand, and document business processes, objectives, specifications, and requirements on medium/large size projects.
• Business acumen in the Quality Manufacturing/Laboratory area.
• Hands-on ability to implement and execute initiatives.
• Leadership.
• Excellent communication abilities.
• Ability to drive change and support others in the change management process.
• Ability to multitask and deliver quality results.
• Ability to work under pressure and tight schedule, with a resourceful, self-driven approach and strong sense of commitment.

Experience

• At least 2 years of experience administering, troubleshooting, and deploying either chromatography systems or lab systems as a whole.

How to Apply

Interested candidates can apply online through the official Takeda Workday application link.