Our client, a world leader in life sciences and biotechnology, is looking for a โSenior GxP Systems & Validation Specialistโ 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:
- Bachelorโs 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