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
Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related Engineering field.
