Principal Product Sustenance Engineer

Job Title: Principal Product Sustenance Engineer

Work Location: Bangalore

Work mode: Hybrid

Shift timings: 12:00 PM to 9:00 PM IST

Job Description:

Role Purpose

IT Solutions Operations Engineer is responsible for the operational excellence reliability and validated state of centrally managed laboratory and business-critical IT applications supporting regulated QC and GxP environments.

The role focuses on day-to-day operations compliance stability and lifecycle management of laboratory applications such as Empower NuGenesis LabSolutions and similar systems ensuring systems remain compliant available and fit for purpose across BPT sites.

This position works closely with QA CSV Infrastructure vendors and business stakeholders to maintain validated systems support audits and deliver controlled system changes.

Key Responsibilities

Operational Support & Stability

• Provide Level 2 / Level 3 operational support for centrally managed laboratory and enterprise applications managing incidents across P1 to P4 severity levels in line with ITIL best practices.
• Perform regular maintenance upgrades patching preventive maintenance and system health checks.
• Proactively monitor applications databases and virtualized environments to prevent service disruption.

Compliance Quality & CSV

• Ensure systems operate in compliance with Gxp data integrity and internal quality requirements.
• Contribute to Computer System Validation (CSV) activities including:
  • IQ OQ PQ execution
  • Risk assessments
  • Data integrity verification
• Ensure alignment with GAMP 5 21 CFR Part 11 and EU Annex 11 principles.
• Support internal and customer audits inspections and validation reviews.

Incident Change & Problem Management

• Manage and coordinate incident change problem and exception management activities.
• Support root cause analysis and contribute to CAPA definition and followup.
• Collaborate with Infrastructure QA CSV teams and vendors to resolve issues efficiently.

Laboratory Application Ownership

• Act as a technical subject matter expert for core laboratory applications like:
  • Empower
  • NuGenesis
  • LabSolutions
  • Other regulated laboratory systems as required (e.g. CDS SDMS instrument control software)
• Coordinate software upgrades configuration changes and lifecycle decisions in collaboration with central teams and sites.
• Interface with application vendors to troubleshoot issues and apply best practices.

Automation & Technical Enablement

• Develop and maintain operational automation scripts to improve stability monitoring and repeatability.
• Support controlled automation initiatives (e.g. job scheduling scripted maintenance validation support activities) where aligned with operational needs and compliance.

Infrastructure Virtualization & Databases

• Use PowerShell and scripting to automate routine tasks monitoring and administrative actions.
• Prepare and maintain automated jobs and scheduled tasks supporting application operations.
• Demonstrate working knowledge of databases (Oracle SQL) relevant to laboratory applications.
• Support virtual machine (VM) environments including:
  • VM build and configuration
  • Maintenance of validated VM images (experience in VM image creation is a strong advantage)

Documentation Reporting & KPIs

• Create and maintain technical documentation operational procedures and system descriptions.
• Support preparation of validation and audit documentation.
• Produce KPIs operational metrics and service reports related to system availability and performance.

Working Model & Availability

• Willingness to work outside business hours or weekends on rare occasions based on:
  • Planned IT changes
  • Critical incidents

Key Competencies & Skills

• Strong experience in IT operations within regulated (GxP) environments
• Solid understanding of CSV data integrity and validation lifecycle
• Hands-on experience with laboratory applications (Empower NuGenesis LabSolutions or similar)
• Proficiency in PowerShell / scripting
• Good knowledge of Oracle and SQL databases
• Experience with virtualized environments; VM image creation is a strong plus
• Strong collaboration skills with QA CSV Infrastructure vendors and business users
• Analytical structured and risk-aware mindset

Qualifications :

Bachelors or Masters degree in Computer Science Software Engineering or a related Engineering field.

Remote Work :

No

Employment Type :

Full-time