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

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 follow‑up.
• 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