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:

• Bachelors 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

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