Quality Systems Engineer Laboratory Systems

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Job Description

Primary Objectives:

Member of the QC Lab Connect team. Manages set of projects and initiatives with the focus on Laboratory Instrument connectivity system (such as Chromeleon and Empower).

Enable Takeda QC Labs with global solutions specifically such as Empower and Chromeleon per global lab systems roadmap:

• The DDT Quality Systems Engineer Lab Systems is a bridge between the Business (Need) and the Technology (Solutions). The Business need can be anything about overall business requirement (Process, Organisation, Integration, etc.) and solutions can be about efficient use of technology (standard tools support by the QC Lab DDT group). The DDT Quality Systems Engineer is required to analyse, transform and ultimately resolve the business problems with the help of technology. End-to-end solution engineering (requirements → design → build/config → test/UAT → release
• The DDT Quality Systems Engineer manages their work with limited supervision and is the technical lead for complex IT systems and projects.
• The DDT Quality Systems Engineer is responsible for support of the DDT systems owned by the group and will be part of the on-call support team once training is complete.

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 the following workflows: Environmental Monitoring, Raw Materials receiving and inspection, Standards and reagent management and testing, Lot/batch QC testing and release, stability testing of products, test instrument management.
• Assess proposed solutions to help the stakeholders select the solution which best fits their requirements.
• Plan the tasks and activities for Business Analysis including stakeholder analysis, managing issues, risks and requirements, and monitoring and reporting on business analysis activities.
• You will oversee and participate in the 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

Education and Experience:

Required:

• Bachelor's degree preferred or relevant work experience in systems or business.
• At least 2 years of experience administering, troubleshooting, and deploying either chromatography systems or lab systems as a whole.
• 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.  Will be expected to interact with stakeholders in multiple parts of the globe.
• Effectively interact with multifunctional teams, included but not limited to Infrastructure, Quality Assurance, Validation, and Quality Control laboratory stakeholders.
• Self-motivated and self-directed in driving results and deliverables
• GxP/CSV validation delivery for lab systems (21 CFR Part 11, EU Annex 11, data integrity/ALCOA+, audit readiness)
• Ability to write and speak in the English language.

Preferred:

• 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/interactions with application vendors such as Waters and Thermo is an advantage.
• Working knowledge of: Change Management
• Gather, understand, and document business processes, objectives, specifications, and requirements on medium/large size projects.

Key Skills and Competencies:

Required:

Technical/Functional (Line) Expertise

• At least 2 years experience administering, troubleshooting, and deploying either chromatography systems or lab systems as a whole.
• Technical troubleshooting skills related to chromatography systems, including windows operating systems, DCOM, active directory, firewalls, etc.
• Incident/problem management for lab-critical systems (triage, root cause, CAPA, vendor escalation, on-call readiness)

Preferred:

• Business acumen in the Quality Manufacturing/Laboratory area.
• Hands-on ability to implement and execute initiatives.

Leadership

• Excellence communication abilities
• Drive change and supports others in the change management process..
• Ability to multitask and deliver quality results.
• Able to work under pressure and tight schedule, resourceful, self-driven with strong sense of commitment.

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time