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” <\/b>based out of Foster City, CA (Hybrid).<\/b><\/span>
<\/p>

 <\/span><\/b>
<\/p>

Job Duration: Long Term Contract (Possibility Of Extension)<\/span><\/b>
<\/p>

Pay Rate: $91/hr on W2<\/span><\/b>
<\/p>

 <\/span><\/b>
<\/p>

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K<\/span><\/b>
<\/p>

 <\/span><\/b>
<\/p>

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.<\/span>
<\/p>

 <\/span><\/b>
<\/p>

Key Responsibilities:<\/span><\/b>
<\/p>

• Administer and support GxP/business applications, including incident resolution, access management, and system monitoring.<\/span>
  <\/li>
• Lead CSV lifecycle activities, including protocol authoring, execution, review, and audit readiness using ValGenesis or equivalent tools.<\/span>
  <\/li>
• Manage quality events such as Change Controls, Deviations, and CAPAs within QMS platforms.<\/span>
  <\/li>
• Perform system maintenance activities including backup/restore testing, disaster recovery validation, server maintenance, and periodic reviews.<\/span>
  <\/li>
• Support cloud/infrastructure operations, system upgrades, migrations, security patching, and on -prem to cloud transitions (AWS/Azure).<\/span>
  <\/li>
• Lead Agile/Scrum activities using tools such as JIRA and Azure DevOps.<\/span>
  <\/li>
• Maintain dashboards, reports, training documentation, and support continuous improvement initiatives.<\/span>
  <\/li>
• Collaborate with cross -functional teams to drive compliant system operations and operational excellence.<\/span>
  <\/li><\/ul>

   <\/span><\/b>
  <\/p>

  Qualifications:<\/span><\/b>
  <\/p>

  • Bachelor’s degree in Computer Science, IT, or related field.<\/span>
    <\/li>
  • 8+ years of experience in GxP system administration and Computer System Validation (CSV).<\/span>
    <\/li>
  • Experience with cloud platforms (AWS/Azure), server/infrastructure management, backup/restore, and disaster recovery.<\/span>
    <\/li>
  • Hands -on experience with validation and quality systems such as ValGenesis, Veeva QMS, or equivalent.<\/span>
    <\/li>
  • Proficiency with JIRA, Azure DevOps, MS Visio, and enterprise IT environments.<\/span>
    <\/li><\/ul>

     <\/span><\/b>
    <\/p>

    Nice to Have:<\/span><\/b>
    <\/p>

    • Exposure to SAP ecosystems.<\/span>
      <\/li>
    • Experience with automation/process optimization (RPA).<\/span>
      <\/li><\/ul>

       <\/span>
      <\/p>

       <\/span>
      <\/p>

      If interested, please send us your updated resume at<\/span>
      <\/p>

      hr@dawarconsulting.com

      akansha@dawarconsulting.com

     <\/span>
    <\/p>

     
    <\/p>

    
    <\/div><\/span>