Our client, a world
leader in life sciences and biotechnology, is looking for a
“Senior GxP
Systems & Validation Specialist”
based out of
Foster City, CA
(Hybrid).
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate: $91/hr on W2
Company
Benefits: Medical, Dental, Vision, Paid Sick leave, 401K
Support the
administration, validation, and operational management of GxP and business
applications within a regulated life sciences environment. Ensure compliant,
reliable, and efficient systems through Computer System Validation (CSV),
infrastructure support, quality event management, and cross-functional
collaboration.
Key Responsibilities:
-
Administer
and support GxP/business applications, including incident resolution,
access management, and system monitoring.
-
Lead
CSV lifecycle activities, including protocol authoring, execution, review,
and audit readiness using ValGenesis or equivalent tools.
-
Manage
quality events such as Change Controls, Deviations, and CAPAs within QMS
platforms.
-
Perform
system maintenance activities including backup/restore testing, disaster
recovery validation, server maintenance, and periodic reviews.
-
Support
cloud/infrastructure operations, system upgrades, migrations, security
patching, and on-prem to cloud transitions (AWS/Azure).
-
Lead
Agile/Scrum activities using tools such as JIRA and Azure DevOps.
-
Maintain
dashboards, reports, training documentation, and support continuous
improvement initiatives.
-
Collaborate
with cross-functional teams to drive compliant system operations and
operational excellence.
Qualifications:
-
Bachelor’s
degree in Computer Science, IT, or related field.
-
8+
years of experience in GxP system administration and Computer System
Validation (CSV).
-
Experience
with cloud platforms (AWS/Azure), server/infrastructure management,
backup/restore, and disaster recovery.
-
Hands-on
experience with validation and quality systems such as ValGenesis, Veeva
QMS, or equivalent.
-
Proficiency
with JIRA, Azure DevOps, MS Visio, and enterprise IT environments.
Nice to Have:
-
Exposure
to SAP ecosystems.
-
Experience
with automation/process optimization (RPA).
If interested, please
send us your updated resume at
hr@dawarconsulting.com
/
akansha@dawarconsulting.com