Senior GxP Systems & Validation Specialist (Biotechnology)

Dawar Consulting•San Mateo, CA

5d•Hybrid

About The Position

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.

Requirements

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 Haves

Exposure to SAP ecosystems.
Experience with automation/process optimization (RPA).

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.