Computer Systems Validation

4 days ago


Hyderabad, Telangana, India KARNYX IT SOLUTIONS Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Hiring Now: Computer Systems Validation (CSV) Engineer – LIMS & Lab Automation Integration

We are seeking an experienced
Computer Systems Validation (CSV) Engineer
to lead validation and testing efforts for a high-impact integration project between
LabVantage LIMS 8.7
and
Hamilton liquid handler
, using the
Scitara DLX
platform.

This role also includes validation and data integration support across analytical platforms like
Spotfire
,
Statistica
, and
AWS Redshift
.


Location:
Hyderabad, India


Client:
Leading US-based Pharmaceutical Company

About the Role:

This is a
critical role
ensuring the integrated systems function as intended and comply with
regulatory requirements
(e.g., GxP, 21 CFR Part 11, Data Integrity).

You will work with a
cross-functional team
including Quality Control (QC), Quality Assurance (QA), IT Infrastructure, and external vendors.

Key Responsibilities:

  • Lead and execute CSV activities for:
    LabVantage LIMS 8.7
    integration with
    Hamilton
    via
    Scitara DLX
  • Visualization and analytical tools (
    Spotfire
    ,
    Statistica
    )
  • Data pipelines using
    AWS Redshift
  • Create and manage all validation documentation (URS, FS, RTM, IQ/OQ/PQ).
  • Perform
    risk-based validation assessments
    ensuring compliance with GxP and data integrity guidelines.
  • Support validation of data integration, reporting, and dashboards.
  • Act as
    CSV SME
    during audits, inspections, and project meetings.

Qualifications:

  • 5+ years of
    hands-on CSV experience
    in regulated (GxP) environments.
  • Proven experience with
    LabVantage LIMS
    ,
    Hamilton systems
    , and/or
    Scitara DLX
    .
  • Working knowledge of
    Spotfire
    ,
    Statistica
    , and
    AWS Redshift
    .
  • Strong grasp of
    data integrity
    ,
    ERES (21 CFR Part 11)
    , and
    risk-based validation approaches
    .
  • Excellent communication and documentation skills.


Interested?

Apply now or reach out to

to learn more



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