Quality Systems Engineer Laboratory Systems

Overview

Quality Systems Engineer for laboratory systems, part of the QC Lab Connect team, working on end-to-end solution delivery for lab instrument connectivity systems like Empower and Chromeleon.

What you'll do

• Analyze and implement solutions for chromatography instrumentation requirements using Empower and Chromeleon.
• Collaborate with Takeda laboratories on workflows including environmental monitoring, raw materials inspection, and QC testing/release.
• Assess proposed solutions to fit stakeholder requirements.
• Plan and manage business analysis activities including stakeholder analysis, issues/risks, and requirements monitoring/reporting.
• Oversee architectural design, development, customization, and integration for lab systems solutions.
• Support DDT systems owned by the group and join on-call support after training.

What you'll need

• At least 2 years administering, troubleshooting, and deploying chromatography systems or lab systems.
• Technical troubleshooting skills for chromatography systems, including Windows operating systems, DCOM, Active Directory, and firewalls.
• Well-developed organizational skills to manage multiple projects simultaneously.
• Ability to interact with stakeholders across the globe.
• GxP/CSV validation delivery for lab systems including 21 CFR Part 11 and EU Annex 11 (data integrity/ALCOA+ and audit readiness).
• Ability to write and speak in English.

Details

• Location: Bengaluru, India.
• Employment type: Full time (Regular Employee).