Computer Systems Validation
3 days ago
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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