Senior GxP Systems & Validation Specialist (Biotechnology)

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